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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Visceral Obesity, Tooth Erosion, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: liquid vinegar
* Dietary Supplement: vinegar pill


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid vinegar<br>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<br>* 6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)<br>* Other names: VIN;|
| Placebo Comparator: Vinegar pill<br>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<br>* Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)<br>* Other names: CON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visceral adiposity | visceral fat as measured by DXA | change after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tooth erosion | dental exam using Basic Erosion Wear Examination (BEWE) | change after 8 weeks of treatment | 
| insulin resistance | measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index) | change after 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trial, vinegar, adiposity, insulin resistance