The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration (VIVO)
Primary Purpose
Visceral Obesity, Tooth Erosion, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
liquid vinegar
vinegar pill
Sponsored by
About this trial
This is an interventional prevention trial for Visceral Obesity focused on measuring randomized clinical trial, vinegar, adiposity, insulin resistance
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Liquid vinegar
Vinegar pill
Arm Description
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.
Participants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial.
Outcomes
Primary Outcome Measures
visceral adiposity
visceral fat as measured by DXA
Secondary Outcome Measures
tooth erosion
dental exam using Basic Erosion Wear Examination (BEWE)
insulin resistance
measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03577834
Brief Title
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Acronym
VIVO
Official Title
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carol Johnston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Obesity, Tooth Erosion, Insulin Resistance
Keywords
randomized clinical trial, vinegar, adiposity, insulin resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
All participants will receive 'vinegar' either in liquid form (active) or pill (not active as acetic acid concentration is below threshold of effect). Investigators measuring outcome variables (visceral fat, tooth enamel, and blood indices) are blinded to treatment assignment.
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liquid vinegar
Arm Type
Experimental
Arm Description
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.
Arm Title
Vinegar pill
Arm Type
Placebo Comparator
Arm Description
Participants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial.
Intervention Type
Dietary Supplement
Intervention Name(s)
liquid vinegar
Other Intervention Name(s)
VIN
Intervention Description
6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
Intervention Type
Dietary Supplement
Intervention Name(s)
vinegar pill
Other Intervention Name(s)
CON
Intervention Description
Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
Primary Outcome Measure Information:
Title
visceral adiposity
Description
visceral fat as measured by DXA
Time Frame
change after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
tooth erosion
Description
dental exam using Basic Erosion Wear Examination (BEWE)
Time Frame
change after 8 weeks of treatment
Title
insulin resistance
Description
measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)
Time Frame
change after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
12. IPD Sharing Statement
Citations:
PubMed Identifier
33297831
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.
Results Reference
derived
Learn more about this trial
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
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