Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-25 @ 3:45 AM
Study NCT ID:
NCT04118257
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2019-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glucose iAUC', 'timeFrame': 'Week 0 and Week 3', 'description': 'Glucose obtained from blood sample in a fasted state and in response to a meal'}], 'secondaryOutcomes': [{'measure': 'Change in plasma lipids', 'timeFrame': 'Week 0 and Week 3', 'description': 'Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal'}, {'measure': 'Change in homeostatic model assessment for insulin resistance', 'timeFrame': 'Week 0 and Week 3', 'description': 'Calculated from fasting glucose and insulin values'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Week 0 and Week 3', 'description': 'Evaluated via automated sphygmomanometer.'}, {'measure': 'Change in BMI', 'timeFrame': 'Week 0 and Week 3', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Change in pulmonary function', 'timeFrame': 'Week 0 and Week 3', 'description': 'Assessed using the maximum flow-volume loop'}, {'measure': 'Change in insulin iAUC', 'timeFrame': 'Week 0 and Week 3', 'description': 'Glucose obtained from blood sample in a fasted state and in response to a meal'}, {'measure': 'Change in serum fructosamine', 'timeFrame': 'Week 0 and Week 3', 'description': 'Fructosamine obtained from blood sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose control', 'Cardiovascular disease risk factors', 'Sugary beverages', 'Pulmonary function'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.', 'detailedDescription': 'In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (\\~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free from diagnosis of diabetes and pulmonary illness\n* Have no intake of glucose or lipid lowering medication.\n\nExclusion Criteria:\n\n* Smoke\n* Currently pregnant\n* Have bronchitis\n* Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).'}, 'identificationModule': {'nctId': 'NCT04118257', 'briefTitle': 'Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Effects of Short-term Sugary Beverage Consumption on Type-2 Diabetes and Cardiovascular Disease Risk Factors: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pro8531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fruit Juice', 'description': 'Participants consumed 2 bottles of 100% fruit juice daily for 3 weeks.', 'interventionNames': ['Dietary Supplement: Sugary beverage: Fruit juice']}, {'type': 'EXPERIMENTAL', 'label': 'Soda', 'description': 'Participants consumed 2 cans of caffeine-free Coca Cola daily for 3 weeks.', 'interventionNames': ['Dietary Supplement: Sugary beverage: Soda']}, {'type': 'OTHER', 'label': 'Water', 'description': 'Participants consumed 2 bottles of water daily for 3 weeks.', 'interventionNames': ['Dietary Supplement: Control: Water']}], 'interventions': [{'name': 'Sugary beverage: Fruit juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consumed 100% fruit juice (\\~710mL) daily for three weeks, along with their habitual diets.', 'armGroupLabels': ['Fruit Juice']}, {'name': 'Sugary beverage: Soda', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consumed soda (\\~710mL) daily for three weeks, along with their habitual diets.', 'armGroupLabels': ['Soda']}, {'name': 'Control: Water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consumed water (\\~710mL) daily for three weeks, along with their habitual diets.', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66502', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Lafene Health Center', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Sara Rosenkranz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara K Rosenkranz', 'investigatorAffiliation': 'Kansas State University'}}}}