Visceral ObesityVIVONCT03577834
The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
A study testing liquid vinegar and vinegar pill in people with Visceral Obesity and Tooth Erosion, run by Carol Johnston.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity, Tooth Erosion, Insulin Resistance
- What is being tested?
- liquid vinegar and vinegar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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".
Read the 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.
- Conditions
- Visceral Obesity, Tooth Erosion, Insulin Resistance
- Being tested
- liquid vinegar, vinegar pill
- Keywords
- randomized clinical trial, vinegar, adiposity, insulin resistance
- Medical subject headings
- Obesity, Abdominal, Tooth Erosion, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid vinegarDietary supplement
Also called VIN
6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
vinegar pillDietary supplement
Also called CON
Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: vinegar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral adiposity
visceral fat as measured by DXA
Measured: change after 8 weeks of treatment
Secondary outcomes (2)
tooth erosion
dental exam using Basic Erosion Wear Examination (BEWE)
Measured: change after 8 weeks of treatment
insulin resistance
measurement of insulin resistance using HOMA-IR (fasting glucose and fasting insulin index)
Measured: change after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start5 Jan 2017
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Johnston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577834
- Sponsor's protocol ID
- vinegar_visceral_fat
- Acronym
- VIVO
- Status last verified
- Aug 2019
- First submitted
- 25 Jun 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33297831
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration
- ClinicalTrials.gov ID
- NCT03577834
- Acronym / sponsor ID
- VIVO / vinegar_visceral_fat
- Conditions
- Visceral Obesity, Tooth Erosion, Insulin Resistance
- Keywords
- randomized clinical trial, vinegar, adiposity, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Carol JohnstonUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Liquid vinegar | Experimental | Dietary Supplement: liquid vinegarParticipants 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. |
| Vinegar pill | Placebo comparator | Dietary Supplement: vinegar pillParticipants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid vinegarAlso: VIN6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid) | Dietary supplement | Liquid vinegar |
| vinegar pillAlso: CONApple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid) | Dietary supplement | Vinegar pill |
Primary outcome
visceral adiposity
Time frame: change after 8 weeks of treatment
visceral fat as measured by DXA
2 secondary outcomes
tooth erosion
Time frame: change after 8 weeks of treatment
insulin resistance
Time frame: change after 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 33297831Anderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing liquid vinegar and vinegar pill in people with Visceral Obesity and Tooth Erosion, run by Carol Johnston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visceral adiposity (time frame: change after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.