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.
Dietary supplement: liquid vinegar
6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
Other Names:
  • VIN
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.
Dietary supplement: vinegar pill
Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
Other Names:
  • CON

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

Carol Johnston

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.

General Publications

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

Keywords

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.

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