NCT03577834

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".

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

June 25, 2018

Last Update Submit

August 26, 2019

Conditions

Keywords

randomized clinical trialvinegaradiposityinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • visceral adiposity

    visceral fat as measured by DXA

    change after 8 weeks of treatment

Secondary Outcomes (2)

  • tooth erosion

    change after 8 weeks of treatment

  • insulin resistance

    change after 8 weeks of treatment

Study Arms (2)

Liquid vinegar

EXPERIMENTAL

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

Vinegar pill

PLACEBO COMPARATOR

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

Interventions

liquid vinegarDIETARY_SUPPLEMENT

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

Also known as: VIN
Liquid vinegar
vinegar pillDIETARY_SUPPLEMENT

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

Also known as: CON
Vinegar pill

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity, AbdominalTooth ErosionInsulin ResistanceObesity

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth WearHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Associated Director

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 5, 2018

Study Start

January 5, 2017

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08