Body CompositionVAnishNCT04706520
Chronic Consumption of Vinegar on Visceral Adiposity in Overweight Adults (VAnish)
A study testing Study Beverage Consumption in people with Body Composition, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
To assess, relative to a placebo, the effects of consuming 400 mL/day or 200 mL/day of a vinegar beverage providing either 1,500 mg/day of acetic acid (in two 200 mL doses daily) or 750 mg/day of acetic acid (in one 200 mL dose daily), respectively, for 12 weeks on VAT (MRI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- What is being tested?
- Study Beverage Consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 4 Nov 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 60 years of age (inclusive) of any ethnicity, free of medications except for oral contraceptives (see inclusion criterion 8).
- Subjects are overweight at screening (Visit 1, Day -14), as defined by a BMI of between 25.0 to ˂30.0 kg/m2, inclusive.
- Subjects have abdominal obesity at screening (Visit 1, Day -14), as defined by a waist circumference of >102 cm for males or >88 cm for females (ATP III, 2001).
- Physical examination and vital signs are normal, or deemed abnormal but clinically insignificant by the Principle and/or Medical Investigator.
- Clinical laboratory evaluations (including but not limited to clinical chemistry [fasted at least 8 hours], including creatine phosphokinase (CPK)], amylase, lipid profile, thyroid stimulating hormone (TSH), free thyroxine (T4), cortisol) complete blood count (CBC), are within the reference ranges for the central laboratory, unless deemed not clinically significant by the Investigator.
- Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method (diaphragm, cervical cap, or condom) plus a contraceptive jelly (spermicidal foam, gel, film, cream, or suppository). If the female sexual partner of the male is using an approved form of contraception (see inclusion criterion 8), the male is not required to be sterile or, if not sterile, to use an approved form of contraception.
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- Female subjects who are postmenopausal (absence of menses for 1 year or more), women who are surgically sterilized, or women of child-bearing potential (WOCBP) who are nonlactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period [effective forms of birth control include oral pills with a concentration of at least 50 μg of the estrogenic component of a biphasic or triphasic pill; transdermal, injectable, or implantable contraceptive; intrauterine device; or double-barrier method (e.g., diaphragm and condom). Abstinence is not considered an acceptable form of birth control.] WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study.
- Subjects who, during the investigative period, are willing to:
- Consume the prescribed amount of vinegar beverage;
- Wear the accelerometer (Fitbit);
- Complete food intake diary as required.
- Collect stool sample
- Willing to archive blood and stool samples
- Subjects who are capable of giving informed consent and complying with all study procedures/ requirements.
Who cannot join
- Subjects who, in the past 6 months, have dieted or have used any supplement/medication intended to affect body weight or suppress appetite
- Subjects with a history of an eating disorder in the last 5 years.
- Subjects who have had or are planning to have bypass surgery, stomach banding surgery, or any other surgical procedure(s), including those of a cosmetic nature, that attempt to aid/promote weight loss or alter body composition.
- Subjects with Type I or Type 2 diabetes mellitus.
- Subjects with endocrine disease (thyroid dysfunction defined by serum levels of T4, TSH or a past diagnosis of Cushing syndrome).
- Subjects who have a history or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological (e.g., HIV/AIDS), dermatologic, urological, neurological, psychiatric, or cardiovascular disease or disorder.
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- Subjects with any implanted electric device (such as a cardiac defibrillator) or other medical device that would allow for them to perform an MRI.
- Women with polycystic ovarian syndrome.
- Women who began taking oral contraceptives or hormone replacement therapy recently, within the last 6 months.
- Women who plan to become pregnant during the study or were pregnant or nursing within the past year.
- Subjects who have recently undergone barium tests/exams (within 7 days), or who have had a nuclear medicine scan or injection with an x-ray dye (within 3 days).
- Subjects who have a history or presence of alcoholism or drug abuse within the previous 2 years and/or a positive urine drug screen at screening.
- Subjects who have quit smoking in the last 6 months or who plan on quitting/altering smoking habits during their participation in this clinical trial.
- Subjects who donated 1 pint or more of blood or blood products within 56 days prior to the study, and/or had a plasma donation within 7 days prior to the study or who plan to donate blood or blood products during their participation in this clinical trial.
- Subjects with poor peripheral venous access that would preclude blood collection.
- Subjects who are currently participating or plan to participate in any other investigational trial in which receipt of an investigational product will occur.
- Subject who resides in the same household as another subject already participating in the study.
- Subjects who have any condition that would make them, in the opinion of the Investigator, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Chronic Consumption of Vinegar on Visceral Adiposity in Overweight Adults
To assess, relative to a placebo, the effects of consuming 400 mL/day or 200 mL/day of a vinegar beverage providing either 1,500 mg/day of acetic acid (in two 200 mL doses daily) or 750 mg/day of acetic acid (in one 200 mL dose daily), respectively, for 12 weeks on VAT (MRI). Thus the 2 active comparator arms 400 mL and 200 mL of vinegar will be independently tested compared to placebo.
Read the detailed description
It has been reported that increased visceral adipose tissue (VAT) is associated with a range of metabolic abnormalities, including decreased glucose tolerance and insulin sensitivity, as well as adverse lipid profiles, all of which are risk factors for type 2 diabetes and CVD (WHO, 2008). In the European Union, a sustained reduction in abdominal fat, and in particular visceral fat, is considered a beneficial physiological effect for adults with adverse health effects associated with excess abdominal fat, including impaired glucose tolerance, dyslipidemia, and hypertension (EFSA, 2012).
This clinical trial is a randomized, double-blinded, placebo-controlled, parallel, single-center study involving a total of 60 male and female adults (aged 18 to 60 years, inclusive) who are overweight (BMI between 25.0 to ˂30.0 kg/m2) and have abdominal obesity (waist circumference >102 cm for males, >88 cm for females) (ATP III, 2001). Each subject's duration of participation will be a total of ~14 weeks, including a ~2-week screening visit and a ~12-week randomized placebo-controlled double-blinded supplementation period.
On the first day of the ~2-week screening period (~Day -14), subjects will be screened according to the study inclusion and exclusion criteria. Subjects meeting all of the inclusion criteria and none of the exclusion criteria will be invited to return to the clinic for a second screening visit (~Day -7). During this second screening visit, subjects will be instructed on how to use the Fitbit (accelerometer) and on how to properly complete the food intake diary. Subjects will be instructed not to alter their dietary intakes or their physical activity levels during the subsequent week, and to record the information as accurately as possible. Participants will be asked to record at least 3 days of physical activity and dietary measurements that includes at least 1 weekend day. Subjects will then be instructed to return to the clinic ~1 week later for the collection of baseline measures (Day 0).
Following the collection of baseline measures on Day 0, subjects will be randomized to the placebo or one of the vinegar groups. Each group will consist of 20 subjects. Randomization will be adaptive according to sex and age; subjects will be asked to return to the clinic twice, once ~11 weeks after the baseline visit to obtain food intake diary, accelerometer, and stool collection materials, and again, ~12 weeks after the baseline visit (i.e., 12 weeks after the baseline visit). Each subject will be required to make a total of 4 visits to the clinical research site (i.e., Days -14, -7, 0, and 84). The entire duration of the clinical study is expected to be approximately 52 weeks from subject enrollment to study closeout.
- Conditions
- Body Composition
- Being tested
- Study Beverage Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Beverage ConsumptionDietary supplement
All participants will follow the same intervention as the study staff is blinded in addition to the participant. Randomized participants will be asked to consume 2 bottles per day of a study beverage for 12 weeks. Compliance checks will occur remotely by having participants send photos of their bottles each day and weekly phone/video calls with intervention staff. Participants will be asked to keep their diet and activity level consistent throughout the 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Vinegar | Experimental | Participants will consume 400 mL/day vinegar beverage providing 1,500 mg/day acetic acid [200 mL vinegar beverage, twice per day (prior to breakfast and dinner)] for 12 weeks. Receives: Dietary Supplement: Study Beverage Consumption |
| Group 2: Vinegar/Placebo Combination | Experimental | Participants will consume 200 mL/day vinegar beverage and 200 mL/day placebo beverage providing 1,200 mg/day lactate [200 mL placebo beverage 1x/day] and 750 mg/day acetic acid [200 mL vinegar beverage 1x/day] (prior to breakfast and dinner) for 12 weeks. Receives: Dietary Supplement: Study Beverage Consumption |
| Group 3: Placebo | Placebo comparator | Participants will consume 400 mL/day placebo beverage containing 1,250 mg/day lactate [200 mL placebo beverage, and 200 mL placebo beverage (prior to breakfast and dinner) for 12 weeks. Receives: Dietary Supplement: Study Beverage Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral Adipose Tissue (VAT)
The primary objective is to assess the effects of consuming vinegar (1500mg/day and 750mg/day) on visceral adipose tissue via MRI as compared to a placebo.
Measured: 12 weeks
Secondary outcomes (2)
Body Weight
A secondary outcome is to assess, relative to a placebo, the effects of consuming vinegar (1500mg/day and 750 mg/day) on body weight.
Measured: 12 weeks
Triglycerides
A secondary outcome is to assess, relative to a placebo, the effects of consuming vinegar (1500mg/day and 750 mg/day) on triglycerides.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start10 Feb 2021
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Why it stopped: study sponsor ended due to recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- VAnish is a randomized, placebo-controlled, parallel study model with 3 groups consisting of 20 participants who will all consume 2 bottles of study product per day. Group 1 will receive 400mL/day of vinegar; Group 2 will receive 200mL/day of vinegar and 200mL/day of the placebo drink; Group 3 will receive 400mL/day of the placebo drink.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mizkan Holdings Co., Ltd.
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
- Investigators
- Frank J Greenway, MD, Principal investigator, Pennington Biomedical Research CenterShengping Yang, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706520
- Sponsor's protocol ID
- PBRC-2020-048
- Acronym
- VAnish
- Status last verified
- Nov 2021
- First submitted
- 7 Jan 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Effects of Chronic Consumption of Vinegar on Visceral Adiposity in Overweight Adults
- ClinicalTrials.gov ID
- NCT04706520
- Acronym / sponsor ID
- VAnish / PBRC-2020-048
- Conditions
- Body Composition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study sponsor ended due to recruitment issues
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Mizkan Holdings Co., Ltd.
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 13 Jan 2021 (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.
To assess, relative to a placebo, the effects of consuming 400 mL/day or 200 mL/day of a vinegar beverage providing either 1,500 mg/day of acetic acid (in two 200 mL doses daily) or 750 mg/day of acetic acid (in one 200 mL dose daily), respectively, for 12 weeks on VAT (MRI). Thus the 2 active comparator arms 400 mL and 200 mL of vinegar will be independently tested compared to placebo.
Detailed description
It has been reported that increased visceral adipose tissue (VAT) is associated with a range of metabolic abnormalities, including decreased glucose tolerance and insulin sensitivity, as well as adverse lipid profiles, all of which are risk factors for type 2 diabetes and CVD (WHO, 2008). In the European Union, a sustained reduction in abdominal fat, and in particular visceral fat, is considered a beneficial physiological effect for adults with adverse health effects associated with excess abdominal fat, including impaired glucose tolerance, dyslipidemia, and hypertension (EFSA, 2012).
This clinical trial is a randomized, double-blinded, placebo-controlled, parallel, single-center study involving a total of 60 male and female adults (aged 18 to 60 years, inclusive) who are overweight (BMI between 25.0 to ˂30.0 kg/m2) and have abdominal obesity (waist circumference >102 cm for males, >88 cm for females) (ATP III, 2001). Each subject's duration of participation will be a total of ~14 weeks, including a ~2-week screening visit and a ~12-week randomized placebo-controlled double-blinded supplementation period.
On the first day of the ~2-week screening period (~Day -14), subjects will be screened according to the study inclusion and exclusion criteria. Subjects meeting all of the inclusion criteria and none of the exclusion criteria will be invited to return to the clinic for a second screening visit (~Day -7). During this second screening visit, subjects will be instructed on how to use the Fitbit (accelerometer) and on how to properly complete the food intake diary. Subjects will be instructed not to alter their dietary intakes or their physical activity levels during the subsequent week, and to record the information as accurately as possible. Participants will be asked to record at least 3 days of physical activity and dietary measurements that includes at least 1 weekend day. Subjects will then be instructed to return to the clinic ~1 week later for the collection of baseline measures (Day 0).
Following the collection of baseline measures on Day 0, subjects will be randomized to the placebo or one of the vinegar groups. Each group will consist of 20 subjects. Randomization will be adaptive according to sex and age; subjects will be asked to return to the clinic twice, once ~11 weeks after the baseline visit to obtain food intake diary, accelerometer, and stool collection materials, and again, ~12 weeks after the baseline visit (i.e., 12 weeks after the baseline visit). Each subject will be required to make a total of 4 visits to the clinical research site (i.e., Days -14, -7, 0, and 84). The entire duration of the clinical study is expected to be approximately 52 weeks from subject enrollment to study closeout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- VAnish is a randomized, placebo-controlled, parallel study model with 3 groups consisting of 20 participants who will all consume 2 bottles of study product per day. Group 1 will receive 400mL/day of vinegar; Group 2 will receive 200mL/day of vinegar and 200mL/day of the placebo drink; Group 3 will receive 400mL/day of the placebo drink.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Vinegar | Experimental | Dietary Supplement: Study Beverage ConsumptionParticipants will consume 400 mL/day vinegar beverage providing 1,500 mg/day acetic acid [200 mL vinegar beverage, twice per day (prior to breakfast and dinner)] for 12 weeks. |
| Group 2: Vinegar/Placebo Combination | Experimental | Dietary Supplement: Study Beverage ConsumptionParticipants will consume 200 mL/day vinegar beverage and 200 mL/day placebo beverage providing 1,200 mg/day lactate [200 mL placebo beverage 1x/day] and 750 mg/day acetic acid [200 mL vinegar beverage 1x/day] (prior to breakfast and dinner) for 12 weeks. |
| Group 3: Placebo | Placebo comparator | Dietary Supplement: Study Beverage ConsumptionParticipants will consume 400 mL/day placebo beverage containing 1,250 mg/day lactate [200 mL placebo beverage, and 200 mL placebo beverage (prior to breakfast and dinner) for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Males and females between 18 and 60 years of age (inclusive) of any ethnicity, free of medications except for oral contraceptives (see inclusion criterion 8).
- Subjects are overweight at screening (Visit 1, Day -14), as defined by a BMI of between 25.0 to ˂30.0 kg/m2, inclusive.
- Subjects have abdominal obesity at screening (Visit 1, Day -14), as defined by a waist circumference of >102 cm for males or >88 cm for females (ATP III, 2001).
- Physical examination and vital signs are normal, or deemed abnormal but clinically insignificant by the Principle and/or Medical Investigator.
- Clinical laboratory evaluations (including but not limited to clinical chemistry [fasted at least 8 hours], including creatine phosphokinase (CPK)], amylase, lipid profile, thyroid stimulating hormone (TSH), free thyroxine (T4), cortisol) complete blood count (CBC), are within the reference ranges for the central laboratory, unless deemed not clinically significant by the Investigator.
Key exclusion criteria (18 listed)
- Subjects who, in the past 6 months, have dieted or have used any supplement/medication intended to affect body weight or suppress appetite
- Subjects with a history of an eating disorder in the last 5 years.
- Subjects who have had or are planning to have bypass surgery, stomach banding surgery, or any other surgical procedure(s), including those of a cosmetic nature, that attempt to aid/promote weight loss or alter body composition.
- Subjects with Type I or Type 2 diabetes mellitus.
- Subjects with endocrine disease (thyroid dysfunction defined by serum levels of T4, TSH or a past diagnosis of Cushing 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 |
|---|---|---|
| Study Beverage ConsumptionAll participants will follow the same intervention as the study staff is blinded in addition to the participant. Randomized participants will be asked to consume 2 bottles per day of a study beverage for 12 weeks. Compliance checks will occur remotely by having participants send photos of their bottles each day and weekly phone/video calls with intervention staff. Participants will be asked to keep their diet and activity level consistent throughout the 12 weeks. | Dietary supplement | Group 1: Vinegar, Group 2: Vinegar/Placebo Combination, Group 3: Placebo |
Primary outcome
Visceral Adipose Tissue (VAT)
Time frame: 12 weeks
The primary objective is to assess the effects of consuming vinegar (1500mg/day and 750mg/day) on visceral adipose tissue via MRI as compared to a placebo.
2 secondary outcomes
Body Weight
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: study sponsor ended due to recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Frank J Greenway, MD principal investigator
Pennington Biomedical Research Center
Shengping Yang, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Beverage Consumption in people with Body Composition, run by Pennington Biomedical Research Center at 1 site in United States.
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 14 inclusion and 18 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: stopped early, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: study sponsor ended due to recruitment issues). Results are not available in the source record.
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 Adipose Tissue (VAT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2021.