Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-08 @ 4:14 AM
Study NCT ID:
NCT02867605
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2016-08-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
Sponsor:
Organization:
Raw JSON
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'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/pretreatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 days of treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'calprotectin', 'categories': [{'measurements': [{'value': '0.00627', 'spread': '0.0033', 'groupId': 'OG000'}, {'value': '0.00828', 'spread': '0.005886', 'groupId': 'OG001'}, {'value': '0.00891', 'spread': '0.00557', 'groupId': 'OG002'}]}]}, {'title': 'human beta-Defensin2', 'categories': [{'measurements': [{'value': '0.0042', 'spread': '0.00660', 'groupId': 'OG000'}, {'value': '0.00535', 'spread': '0.01046', 'groupId': 'OG001'}, {'value': '0.00362', 'spread': '0.00814', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28', 'unitOfMeasure': 'ng/ug', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/PreTreatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately Post 7 days of treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 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[{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre-treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'immediately post 7 days of treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '13.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '13.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Protein', 'categories': [{'measurements': [{'value': '7.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Albumin', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, day 8 day 28', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'White Blood Cell', 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '263', 'spread': '59', 'groupId': 'OG000'}, {'value': '262', 'spread': '63', 'groupId': 'OG001'}, {'value': '271', 'spread': '64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, day 8, and day 28', 'unitOfMeasure': 'k/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'Alkaline Phosphatase', 'categories': [{'measurements': [{'value': '66', 'spread': '16', 'groupId': 'OG000'}, {'value': '66', 'spread': '17', 'groupId': 'OG001'}, {'value': '67', 'spread': '17', 'groupId': 'OG002'}]}]}, {'title': 'aspartate transaminase', 'categories': [{'measurements': [{'value': '18', 'spread': '6', 'groupId': 'OG000'}, {'value': '22', 'spread': '18', 'groupId': 'OG001'}, {'value': '19', 'spread': '7', 'groupId': 'OG002'}]}]}, {'title': 'alanine transaminase', 'categories': [{'measurements': [{'value': '16', 'spread': '7', 'groupId': 'OG000'}, {'value': '15', 'spread': '6', 'groupId': 'OG001'}, {'value': '18', 'spread': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, day 8, and day 28', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'Sodium', 'categories': [{'measurements': [{'value': '140', 'spread': '1', 'groupId': 'OG000'}, {'value': '140', 'spread': '2', 'groupId': 'OG001'}, {'value': '140', 'spread': '2', 'groupId': 'OG002'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '4.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'carbon dioxide', 'categories': [{'measurements': [{'value': '25', 'spread': '2', 'groupId': 'OG000'}, {'value': '24', 'spread': '2', 'groupId': 'OG001'}, {'value': '24', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, day 8, and day 28', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'title': 'Resting Energy Expenditure', 'categories': [{'measurements': [{'value': '1556.3', 'spread': '274.5', 'groupId': 'OG000'}, {'value': '1562.8', 'spread': '221.4', 'groupId': 'OG001'}, {'value': '1670.6', 'spread': '333.9', 'groupId': 'OG002'}]}]}, {'title': 'Metabolic Rate', 'categories': [{'measurements': [{'value': '1653.1', 'spread': '268.7', 'groupId': 'OG000'}, {'value': '1665.2', 'spread': '258.8', 'groupId': 'OG001'}, {'value': '1668.4', 'spread': '259.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, day 8, and day 28', 'unitOfMeasure': 'kilocalories/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 0', 'description': 'Baseline/Pre Treatment'}, {'id': 'OG001', 'title': 'Day 8', 'description': 'Immediately post 7 day treatment'}, {'id': 'OG002', 'title': 'Day 28', 'description': '28 days post treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '95.89', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '95.67', 'spread': '12.94', 'groupId': 'OG001'}, {'value': '101.39', 'spread': '10.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, day 8, and day 28', 'description': 'This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.', 'unitOfMeasure': 'percent of age/gender predicted values', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35', 'description': 'Hyaluronan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35', 'description': 'Hyaluronan'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-18', 'size': 80225, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-19T07:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2016-08-09', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-29', 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days', 'timeFrame': 'Baseline, Day 8, Day 28', 'description': 'Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes'}, {'measure': 'Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ', 'timeFrame': 'Baseline, Day 8, Day 28', 'description': 'The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration. It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions. A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates'}, {'measure': 'Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein', 'timeFrame': 'Baseline, Day 8, Day 28'}, {'measure': 'Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28', 'timeFrame': 'Baseline, day 8 day 28'}, {'measure': 'White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28', 'timeFrame': 'baseline, day 8, and day 28'}, {'measure': 'Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28', 'timeFrame': 'baseline, day 8, and day 28'}, {'measure': 'Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28', 'timeFrame': 'baseline, day 8, and day 28'}, {'measure': 'Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28', 'timeFrame': 'Baseline, day 8, and day 28'}, {'measure': 'Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28', 'timeFrame': 'Baseline, day 8, and day 28', 'description': 'This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.'}]}, 'conditionsModule': {'conditions': ['Gastrointestinal Microbiome']}, 'referencesModule': {'references': [{'pmid': '22761444', 'type': 'BACKGROUND', 'citation': 'Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human beta-defensin 2 in intestinal epithelium. J Biol Chem. 2012 Aug 31;287(36):30610-24. doi: 10.1074/jbc.M112.356238. Epub 2012 Jul 3.'}, {'pmid': '23950179', 'type': 'BACKGROUND', 'citation': 'Hill DR, Rho HK, Kessler SP, Amin R, Homer CR, McDonald C, Cowman MK, de la Motte CA. Human milk hyaluronan enhances innate defense of the intestinal epithelium. J Biol Chem. 2013 Oct 4;288(40):29090-104. doi: 10.1074/jbc.M113.468629. Epub 2013 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 19-25 (lean), and BMI 30-35 (obese)\n* Age 18-45 years old\n* Willingness to take oral supplement and adhere to study requirements\n\nExclusion Criteria:\n\n* Diabetes\n* Oral antibiotics within 4 weeks of study initiation\n* History of cardiac disease, and medications for cardiac disease\n* Use statins and antihypertensive drugs\n* Inflammatory bowel disease including irritable bowel syndrome\n* History of intestinal surgery, excluding hernia repair and appendectomy\n* Active cancer diagnosis (except skin cancer)\n* Chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)\n* Immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)\n* Vegetarian or vegan diet7\n* Abnormal liver or kidney function as measured by routine serum chemistry testing\n* Severe anemia or significant white blood cell or platelet abnormalities\n* No additional blood or blood product donations during the study'}, 'identificationModule': {'nctId': 'NCT02867605', 'briefTitle': 'Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'orgStudyIdInfo': {'id': '16-142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Controls ages 18-45 with BMI of 19-25 or 30-35', 'description': 'Single Arm study', 'interventionNames': ['Dietary Supplement: Hyaluronan']}], 'interventions': [{'name': 'Hyaluronan', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Healthy Controls ages 18-45 with BMI of 19-25 or 30-35']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoiciate Staff', 'investigatorFullName': 'Carol De La Motte', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}