- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577834
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration (VIVO)
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.
Research 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".
H2 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".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nonsmoking
- Not pregnant or lactating if female
- 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)
- No food restrictions or special diet
- BMI range: 22-35
- Waist circumference >34 (women) and >39 (males)
- Sedentary (exercising < 3 days/week)
Exclusion Criteria:
- Unwilling to take a vinegar supplement daily for 8 week or follow other aspects of study protocol
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liquid vinegar
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.
|
6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
Other Names:
|
Placebo Comparator: Vinegar pill
Participants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial.
|
Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visceral adiposity
Time Frame: change after 8 weeks of treatment
|
visceral fat as measured by DXA
|
change after 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tooth erosion
Time Frame: change after 8 weeks of treatment
|
dental exam using Basic Erosion Wear Examination (BEWE)
|
change after 8 weeks of treatment
|
insulin resistance
Time Frame: change after 8 weeks of treatment
|
measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)
|
change after 8 weeks of treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vinegar_visceral_fat
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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