The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration (VIVO)
August 26, 2019 updated by: Carol Johnston
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
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2017
Primary Completion (Actual)
August 15, 2018
Study Completion (Actual)
August 15, 2018
Study Registration Dates
First Submitted
June 25, 2018
First Submitted That Met QC Criteria
June 25, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 26, 2019
Last Verified
August 1, 2019
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
No
Studies a U.S. FDA-regulated device product
No
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.