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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
Carol Johnston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Visceral Obesity focused on measuring randomized clinical trial, vinegar, adiposity, insulin resistance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 25, 2018
    Last Updated
    August 26, 2019
    Sponsor
    Carol Johnston
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    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

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

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