Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT03577834
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D014077', 'term': 'Tooth Erosion'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D057085', 'term': 'Tooth Wear'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019342', 'term': 'Acetic Acid'}], 'ancestors': [{'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "All participants will receive 'vinegar' either in liquid form (active) or pill (not active as acetic acid concentration is below threshold of effect). Investigators measuring outcome variables (visceral fat, tooth enamel, and blood indices) are blinded to treatment assignment."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Qualifying participants will be stratified by gender, age, weight, and waist circumference, then randomized into two groups: the intervention group, vinegar drinks (VIN) or the control group, vinegar pills (CON).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visceral adiposity', 'timeFrame': 'change after 8 weeks of treatment', 'description': 'visceral fat as measured by DXA'}], 'secondaryOutcomes': [{'measure': 'tooth erosion', 'timeFrame': 'change after 8 weeks of treatment', 'description': 'dental exam using Basic Erosion Wear Examination (BEWE)'}, {'measure': 'insulin resistance', 'timeFrame': 'change after 8 weeks of treatment', 'description': 'measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomized clinical trial', 'vinegar', 'adiposity', 'insulin resistance'], 'conditions': ['Visceral Obesity', 'Tooth Erosion', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '33297831', 'type': 'DERIVED', 'citation': 'Anderson S, Gonzalez LA, Jasbi P, Johnston CS. Evidence That Daily Vinegar Ingestion May Contribute to Erosive Tooth Wear in Adults. J Med Food. 2021 Aug;24(8):894-896. doi: 10.1089/jmf.2020.0108. Epub 2020 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the potential ability of vinegar to significantly decrease visceral fat in healthy adults with "central obesity". During the 8-week trial, participants will either consume a low-dose vinegar pill (control treatment) or a vinegar drink twice per day.\n\nResearch Aim and Hypothesis H1 Daily vinegar consumption will be associated with loss in visceral fat (as measured by DXA) after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity".\n\nH2 Daily vinegar consumption will be associated with a decrease in abdominal circumference after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity".', 'detailedDescription': 'This randomized, placebo-controlled experimental trial will last 8 weeks. At the initial visit (consenting visit lasting about 20 minutes) the participant will sign the consent and complete a short health questionnaire and a short questionnaire on tooth erosion. Body height and weight and waist circumference will also be measured. Qualifying participants will be stratified by gender, age, weight, and waist circumference, then randomized into two groups: the intervention group, vinegar drinks (VIN) or the control group, vinegar pills (CON). The participants will know which treatment they are given but they will not know which group (control vs. placebo) they are in. Those who receive the VIN will be instructed to drink 2 tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8 of the trial. Those in the CON group will be instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial. Participants will be instructed to maintain their current diet and exercise habits during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Nonsmoking\n* Not pregnant or lactating if female\n* No active disease state or medication use affecting blood glucose or cholesterol (additionally, individuals on digoxin or diuretics will be excluded but other medications in use \\>3 months will be allowed)\n* No food restrictions or special diet\n* BMI range: 22-35\n* Waist circumference \\>34 (women) and \\>39 (males)\n* Sedentary (exercising \\< 3 days/week)\n\nExclusion Criteria:\n\n* Unwilling to take a vinegar supplement daily for 8 week or follow other aspects of study protocol\n* Recent abdominal surgery or condition causing abdominal discomfort/distention (such as acid reflux, ascites, pancreatitis, diverticulitis/diverticulosis, Crohn's disease, and/or irritable bowel syndrome)"}, 'identificationModule': {'nctId': 'NCT03577834', 'acronym': 'VIVO', 'briefTitle': 'The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration', 'orgStudyIdInfo': {'id': 'vinegar_visceral_fat'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liquid vinegar', 'description': 'Participants in this arm were instructed to drink 2 tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8 of the trial.', 'interventionNames': ['Dietary Supplement: liquid vinegar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vinegar pill', 'description': 'Participants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial.', 'interventionNames': ['Dietary Supplement: vinegar pill']}], 'interventions': [{'name': 'liquid vinegar', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['VIN'], 'description': '6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)', 'armGroupLabels': ['Liquid vinegar']}, {'name': 'vinegar pill', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CON'], 'description': 'Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)', 'armGroupLabels': ['Vinegar pill']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carol Johnston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Associated Director', 'investigatorFullName': 'Carol Johnston', 'investigatorAffiliation': 'Arizona State University'}}}}