Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
Study NCT ID:
NCT03783195
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2018-12-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Genetic-specific Effects of Fructose on Liver Lipogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080845', 'term': 'Sugar-Sweetened Beverages'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'saroja@unc.edu', 'phone': '704-250-5009', 'title': 'Saroja Voruganti, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing informed consent through completion of study, a total of 3 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Liver Fat Content Based on Elastography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '0.76', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Elastography (Fibroscan) will be used to measure changes in liver fat.', 'unitOfMeasure': 'kilopascal (kPa)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change in Liver Fat Content Based on MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-3.33', 'ciUpperLimit': '2.57', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.93', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction).', 'unitOfMeasure': 'Percent fat fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 limitations, only 4 participants had both the Week 0 (Baseline) and Week 3 MRIs.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.02', 'ciLowerLimit': '-31.33', 'ciUpperLimit': '-10.72', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.80', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'PRIMARY', 'title': 'Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.094', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'mg*hr/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '21.75', 'spread': '60.6', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '29.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.06', 'ciLowerLimit': '-37.75', 'ciUpperLimit': '-4.38', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.77', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.022', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'mg*hr/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.70', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '20.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.36', 'ciLowerLimit': '-14.28', 'ciUpperLimit': '5.55', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.62', 'groupDescription': 'The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.067', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum HDL cholesterol for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'mg*hr/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.40', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.03', 'ciLowerLimit': '-45.76', 'ciUpperLimit': '3.69', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.53', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum LDL cholesterol for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'mg*hr/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.77', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '25.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.61', 'ciLowerLimit': '-62.39', 'ciUpperLimit': '3.17', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.28', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.036', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'week 0 and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum total cholesterol for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'mg*hr/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescent and young adults of Caucasian descent.'}, {'type': 'SECONDARY', 'title': 'Mean Changes in Serum Concentrations of Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.91', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum uric acid (ng/ml) will be measured at week 0 and week 3', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Changes in AUC of Serum Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.217', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (ng\\*hr/ml) of serum uric acid for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '-0.0009', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.007', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum ALT (nmol) will be measured at week 0 and week 3', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Alanine Transaminase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.121', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (nmol/hr) of serum ALT for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'nmol/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.57', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '58.08', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.5', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Serum concentrations of serum AST will be measured at week 0 and week 3', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Aspartate Transaminase (AST).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (IU\\*hr/L) of serum AST for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'IU*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '20.38', 'spread': '71.14', 'groupId': 'OG000'}, {'value': '-5.24', 'spread': '21.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.95', 'ciLowerLimit': '-17.76', 'ciUpperLimit': '75.67', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.78', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum ALP (nmol) will be measured at week 0 and week3', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciLowerLimit': '-0.214', 'ciUpperLimit': '0.321', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (nmol/hr) of serum ALP for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'nmol/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.28', 'pValueComment': 'All tests were individual tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different.'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Serum concentrations of GGT will be measured at week 0 and week 3', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}, {'type': 'SECONDARY', 'title': 'Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'OG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.109', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Both groups received the same intervention; however, their genetic make-up was different'}], 'paramType': 'MEAN', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (IU\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.', 'unitOfMeasure': 'IU*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Adolescents and young adults of Caucasian descent'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Genetic Risk Score (GRS) Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'FG001', 'title': 'Low Genetic Risk Score (GRS) Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High GRS Group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'BG001', 'title': 'Low GRS Group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.\n\nSugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.88', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '24', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '25.53', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Same as participant flow.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-15', 'size': 423774, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-22T15:25', 'hasProtocol': True}, {'date': '2021-03-09', 'size': 887196, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-16T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to high genetic risk score group in parallel to low genetic risk score group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2024-03-28', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2018-12-17', 'resultsFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2018-12-19', 'dispFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-27', 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Liver Fat Content Based on Elastography', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Elastography (Fibroscan) will be used to measure changes in liver fat.'}, {'measure': 'Mean Percent Change in Liver Fat Content Based on MRI', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction).'}, {'measure': 'Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3.'}, {'measure': 'Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Serum Concentrations of Triglycerides', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3'}, {'measure': 'Mean Change in AUC of Serum Triglycerides', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of HDL Cholesterol', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3.'}, {'measure': 'Mean Change in AUC of Serum HDL Cholesterol', 'timeFrame': 'between week 0 (baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum HDL cholesterol for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of LDL Cholesterol', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3'}, {'measure': 'Mean Change in AUC of Serum LDL Cholesterol', 'timeFrame': 'Week 0 (baseline) and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum LDL cholesterol for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of Total Cholesterol', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3'}, {'measure': 'Mean Change in AUC of Serum Total Cholesterol', 'timeFrame': 'week 0 and week 3', 'description': 'Area under curve (AUC) (mg\\*hr/dl) of serum total cholesterol for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Changes in Serum Concentrations of Uric Acid', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum uric acid (ng/ml) will be measured at week 0 and week 3'}, {'measure': 'Mean Changes in AUC of Serum Uric Acid', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (ng\\*hr/ml) of serum uric acid for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT).', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum ALT (nmol) will be measured at week 0 and week 3'}, {'measure': 'Mean Change in AUC of Serum Alanine Transaminase (ALT)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (nmol/hr) of serum ALT for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST).', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Serum concentrations of serum AST will be measured at week 0 and week 3'}, {'measure': 'Mean Change in AUC of Serum Aspartate Transaminase (AST).', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (IU\\*hr/L) of serum AST for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Fasting concentrations of serum ALP (nmol) will be measured at week 0 and week3'}, {'measure': 'Mean Change in AUC of Serum Alkaline Phosphatase (ALP)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (nmol/hr) of serum ALP for baseline and 3hr time points at week 0 and Week 3.'}, {'measure': 'Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Serum concentrations of GGT will be measured at week 0 and week 3'}, {'measure': 'Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT)', 'timeFrame': 'between week 0 (Baseline) and week 3', 'description': 'Area under curve (AUC) (IU\\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose', 'Fructose', 'Fatty-liver', 'Polymorphisms', 'Imaging', 'Fibroscan'], 'conditions': ['NAFLD']}, 'referencesModule': {'references': [{'pmid': '27543837', 'type': 'BACKGROUND', 'citation': 'Younossi ZM, Blissett D, Blissett R, Henry L, Stepanova M, Younossi Y, Racila A, Hunt S, Beckerman R. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016 Nov;64(5):1577-1586. doi: 10.1002/hep.28785. Epub 2016 Sep 26.'}, {'pmid': '18769702', 'type': 'BACKGROUND', 'citation': 'Vos MB, Kimmons JE, Gillespie C, Welsh J, Blanck HM. Dietary fructose consumption among US children and adults: the Third National Health and Nutrition Examination Survey. Medscape J Med. 2008 Jul 9;10(7):160.'}, {'pmid': '25514388', 'type': 'BACKGROUND', 'citation': 'Moore JB, Gunn PJ, Fielding BA. The role of dietary sugars and de novo lipogenesis in non-alcoholic fatty liver disease. Nutrients. 2014 Dec 10;6(12):5679-703. doi: 10.3390/nu6125679.'}, {'pmid': '15983189', 'type': 'BACKGROUND', 'citation': 'Faeh D, Minehira K, Schwarz JM, Periasamy R, Park S, Tappy L. Effect of fructose overfeeding and fish oil administration on hepatic de novo lipogenesis and insulin sensitivity in healthy men. Diabetes. 2005 Jul;54(7):1907-13. doi: 10.2337/diabetes.54.7.1907.'}, {'pmid': '27995280', 'type': 'BACKGROUND', 'citation': 'Alwahsh SM, Gebhardt R. Dietary fructose as a risk factor for non-alcoholic fatty liver disease (NAFLD). Arch Toxicol. 2017 Apr;91(4):1545-1563. doi: 10.1007/s00204-016-1892-7. Epub 2016 Dec 19.'}, {'pmid': '19381015', 'type': 'BACKGROUND', 'citation': 'Stanhope KL, Schwarz JM, Keim NL, Griffen SC, Bremer AA, Graham JL, Hatcher B, Cox CL, Dyachenko A, Zhang W, McGahan JP, Seibert A, Krauss RM, Chiu S, Schaefer EJ, Ai M, Otokozawa S, Nakajima K, Nakano T, Beysen C, Hellerstein MK, Berglund L, Havel PJ. Consuming fructose-sweetened, not glucose-sweetened, beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans. J Clin Invest. 2009 May;119(5):1322-34. doi: 10.1172/JCI37385. 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To determine the impact of prolonged exposure of fructose on hepatic lipid accumulation in Caucasian individuals with high and low genetic risk for NAFLD,\n2. to determine the impact of acute exposure of fructose on hepatic DNL, and\n3. to determine the relationship between markers of DNL, liver fat accumulation and serum concentrations of lipids, uric acid and liver function markers before and after the fructose challenge.', 'detailedDescription': 'BACKGROUND AND RATIONALE Non-alcoholic fatty liver disease (NAFLD) is characterized by fat accumulation in liver cells not caused by alcohol. A leading cause of chronic liver disease in the US, NAFLD represents a group of disorders including steatosis, nonalcoholic steatohepatitis with fibrosis. It has substantially risen in prevalence over the last two decades with the estimated prevalence being 20% among US adults and 25% in young adults (18-39 years). Over 64 million individuals are believed to have NAFLD with annual medical costs rising to more $100 billion. More common in individuals who are obese or diabetic and/or have metabolic syndrome, NAFLD has been associated with increased cirrhosis, liver-related mortality and hepatocellular carcinoma.\n\nBoth genetic and environmental, including nutritional, factors contribute to the onset and progression of NAFLD. Increased consumption of sugar-sweetened, fructose-rich beverages has been linked to NAFLD. Fructose, commonly found in soft drinks, fruit juices and energy drinks, affects many metabolic processes, foremost being an increase in fat accumulation in the liver and hence, NAFLD. Genome-wide and candidate gene studies have identified several genes associated with NAFLD. However, none of these studies have shown the cumulative effects of single nucleotide polymorphisms (SNPs) on changes in liver fat when exposed to fructose. The results from this study can be extrapolated to larger cohorts and other ethnicities and are therefore, expected to lay the foundation for developing personalized nutritional plans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects 12 - 40 years\n2. No history of alcohol abuse (\\> 7 drinks per week)\n3. History of fructose intake of \\< 14 drinks per week\n4. Caucasian ethnicity\n5. BMI \\> 25kg/m² - 32kg/m² or 85th -99th percentile but otherwise healthy\n\nExclusion Criteria:\n\n1. ages \\< 12 and \\> 40 years\n2. Pregnant/lactating\n3. known alcohol abuse or fructose intake \\> 14 drinks per week\n4. not of Caucasian ethnicity\n5. glucose levels \\> 100 mg/dL if fasting, \\> 140mg/dL if within 2 hours post meal and \\> 200 mg/dL if random sample\n6. taking anti-hypertensive, anti-diabetic, uric acid and/or lipid-lowering medications\n7. known diagnosis of diabetes, fructose intolerance, chronic kidney disease, NAFLD or any liver-related disease, hypertriglyceridemia, polycystic ovary syndrome, hypothyroidism, obstructive sleep apnea, hypopituitarism and hypogonadism\n8. BMI \\< 25kg/m² or \\> 32 kg/m² or \\< 85th or \\> 99th percentile\n9. Liver fat fraction \\>5% as per baseline MRI scan'}, 'identificationModule': {'nctId': 'NCT03783195', 'briefTitle': 'Genetic-specific Effects of Fructose on Liver Lipogenesis', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Genetic-specific Effects of Fructose on Liver Lipogenesis', 'orgStudyIdInfo': {'id': '17-3348'}, 'secondaryIdInfos': [{'id': 'P30DK056336-16S1', 'link': 'https://reporter.nih.gov/quickSearch/P30DK056336-16S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High GRS group', 'description': 'This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.', 'interventionNames': ['Other: Sugar drink']}, {'type': 'EXPERIMENTAL', 'label': 'Low GRS group', 'description': 'This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.', 'interventionNames': ['Other: Sugar drink']}], 'interventions': [{'name': 'Sugar drink', 'type': 'OTHER', 'description': 'A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water', 'armGroupLabels': ['High GRS group', 'Low GRS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Nutrition Research Institute', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}], 'overallOfficials': [{'name': 'Saroja Voruganti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '9- 36 months following article publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by the institutional review board, independent ethics committee or research ethics committee, as applicable and an executed data use agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}