Clinical trial NCT03577834: The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Official title: The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Obesity
Tooth Erosion
Insulin Resistance
Keywords: randomized clinical trial
vinegar
adiposity
insulin resistance
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: visceral adiposity
timeFrame: change after 8 weeks of treatment
Secondary outcomes:
measure: tooth erosion
timeFrame: change after 8 weeks of treatment
measure: insulin resistance
timeFrame: change after 8 weeks of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Anderson S, Gonzalez LA, Jasbi P, Johnston CS. Evidence That Daily Vinegar Ingestion May Contribute to Erosive Tooth Wear in Adults. J Med Food. 2021 Aug;24(8):894-896. doi: 10.1089/jmf.2020.0108. Epub 2020 Dec 9.