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

Insulin Resistance Clinical Trial

— VIVO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577834
• Other study ID #: vinegar_visceral_fat
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: August 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity, Abdominal
• Tooth Erosion
• Visceral Obesity

Intervention

Dietary Supplement:
• liquid vinegar
6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
• vinegar pill
Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carol Johnston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visceral adiposity	visceral fat as measured by DXA	change after 8 weeks of treatment
Secondary	tooth erosion	dental exam using Basic Erosion Wear Examination (BEWE)	change after 8 weeks of treatment
Secondary	insulin resistance	measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)	change after 8 weeks of treatment