InflammationNCT05698381
Daily Vinegar Ingestion and Metabolic Health
A study testing Liquid vinegar and Vinegar pill in people with Inflammation and Metabolic Syndrome, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Metabolic Syndrome, Depression
- 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 15 Aug 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoker
- free of chronic disease by self-report
- able to speak, read, and understand English
- able to consent.
- BMI ≥ 25 and ≤ 35
Who cannot join
- adherence to specific diets for weight loss
- vegetarian
- report GERD or regular heartburn
- unwilling to consume vinegar daily for 4 weeks
- pregnant or lactating women
- recreational drug use, alcohol intake above recommendations (1 drink/day for women, 2 drinks/day for men - or none)
- competitive level physical training (e.g., physical activity above recommendations as set by the Physical Activity Guidelines for Americans)
- scoring 1 or higher on question 9 of the PHQ-9 questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults
The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.
Read the detailed description
Recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. The study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. Although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. It is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.
- Conditions
- Inflammation, Metabolic Syndrome, Depression
- Being tested
- Liquid vinegar, Vinegar pill
- Keywords
- vinegar, acetic acid, LPS
- Medical subject headings
- Inflammation, Metabolic Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid vinegarDietary supplement
2 tablespoons consumed twice daily with meals
Vinegar pillDietary supplement
2 pills consumed upon waking
| Study group | Role | What they receive |
|---|---|---|
| Liquid vinegar | Experimental | 4 tablespoons BID per day (3000 mg acetic acid) Receives: Dietary Supplement: Liquid vinegar |
| Vinegar pill | Placebo comparator | 2 vinegar pills per day (30 mg acetic acid) Receives: Dietary Supplement: Vinegar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression score
Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)
Measured: change from baseline at week 4
Depression score
Center for Epidemiologic Studies Depression Scale (CES-D); scores range from 0 to 60 (higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression).
Measured: change from baseline at week 4
gamma-aminobutyric acid (GABA)
Blood levels of the neurotransmitter GABA
Measured: change from baseline at week 4
Secondary outcomes (3)
metabolic syndrome
A cluster of conditions that increase risk of heart disease, stroke and type 2 diabetes: increased blood pressure, high blood sugar, waist circumference, and abnormal cholesterol or triglyceride levels. siMS score = 2*Waist/Height + Gly/5.6 + Tg/1.7 + TAsystolic/130-HDL/1.02 or 1.28 (for male or female subjects, respectively) (adapted from Soldatovic et al. (2016) siMS Score: Simple Method for Quantifying Metabolic Syndrome. PLoS ONE 11(1): e014614)
Measured: change from baseline at week 4
Inflammation
Blood C-reactive protein
Measured: change from baseline at week 4
LPS
Blood Lipopolysaccharide binding protein
Measured: change from baseline at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
- Investigators
- Carol S Johnston, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698381
- Sponsor's protocol ID
- STUDY00017204
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2023
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults
- ClinicalTrials.gov ID
- NCT05698381
- Acronym / sponsor ID
- STUDY00017204
- Conditions
- Inflammation, Metabolic Syndrome, Depression
- Keywords
- vinegar, acetic acid, LPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 26 Jan 2023 (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 determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.
Detailed description
Recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. The study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. Although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. It is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Liquid vinegar | Experimental | Dietary Supplement: Liquid vinegar4 tablespoons BID per day (3000 mg acetic acid) |
| Vinegar pill | Placebo comparator | Dietary Supplement: Vinegar pill2 vinegar pills per day (30 mg acetic acid) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy
- non-smoker
- free of chronic disease by self-report
- able to speak, read, and understand English
- able to consent.
Key exclusion criteria (8 listed)
- adherence to specific diets for weight loss
- vegetarian
- report GERD or regular heartburn
- unwilling to consume vinegar daily for 4 weeks
- pregnant or lactating women
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 vinegar2 tablespoons consumed twice daily with meals | Dietary supplement | Liquid vinegar |
| Vinegar pill2 pills consumed upon waking | Dietary supplement | Vinegar pill |
Primary outcome
Depression score
Time frame: change from baseline at week 4
Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)
Depression score
Time frame: change from baseline at week 4
Center for Epidemiologic Studies Depression Scale (CES-D); scores range from 0 to 60 (higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression).
gamma-aminobutyric acid (GABA)
Time frame: change from baseline at week 4
Blood levels of the neurotransmitter GABA
3 secondary outcomes
metabolic syndrome
Time frame: change from baseline at week 4
Inflammation
Time frame: change from baseline at week 4
LPS
Time frame: change from baseline at week 4
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 31 Jan 2024.
- 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.
Carol S Johnston, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid vinegar and Vinegar pill in people with Inflammation and Metabolic Syndrome, run by Arizona State University 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 6 inclusion and 8 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 31 Jan 2024. 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 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?
Depression score (time frame: change from baseline at week 4). The study lists 3 primary outcomes in all. 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 31 Jan 2024.