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Completed

NCT Number: NCT03577834

The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration

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".

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liquid vinegar

Dietary Supplement

6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)

Other names: VIN

Vinegar pill

Dietary Supplement

Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)

Other names: CON

Primary outcomes

  1. visceral adiposity

    Time frame: change after 8 weeks of treatment

    visceral fat as measured by DXA

Secondary outcomes

  1. tooth erosion

    Time frame: change after 8 weeks of treatment

    dental exam using Basic Erosion Wear Examination (BEWE)

  2. insulin resistance

    Time frame: change after 8 weeks of treatment

    measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)

Sponsors and collaborators

Lead sponsor

Carol Johnston

Other

Registry information

Acronym: VIVO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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