MoodVIN2020NCT04706806
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students
A study testing apple cider vinegar and vinegar pill in people with Mood and Depression, run by Arizona State University at 1 site in United States.
Trial summary
The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood, Depression
- What is being tested?
- apple cider 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 17 Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- college student, non-athlete, no chronic health condition
Who cannot join
- vegetarians or others adhering to special diet, body mass index >30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion.
Read the detailed description
Recent research suggests that fruit and vegetable intake is inversely associated with mood states and depression. Although the mechanism is not known, increased gut fermentation is suspected as changes in gut tryptophan metabolism was noted in these trials. Tryptophan is the precursor to serotonin, the neurotransmitter associated with improved mood state, but other metabolites of tryptophan have been associated with mental wellbeing as well. The main ingredient of vinegar, acetic acid, is the most common metabolite produced during gut fermentation of dietary fiber (mainly from fruits and vegetables) and can also be expected to influence the gut microbiome. It has been reported that vinegar ingestion is linked to a change in tryptophan metabolism in healthy adults consuming vinegar daily for 8 weeks. This study will explore the impact of vinegar ingestion on mood states.
- Conditions
- Mood, Depression
- Being tested
- apple cider vinegar, vinegar pill
- Keywords
- acetic acid
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apple cider vinegarDietary supplement
Also called apple cider vinegar (Bragg Live Food Products, LLC)
2 tablespoons diluted in water taken twice daily with meals
vinegar pillDietary supplement
Also called Nature's Bounty Apple Cider Vinegar pills
one pill taken daily
| Study group | Role | What they receive |
|---|---|---|
| liquid vinegar | Experimental | 2 tablespoons (diluted in water) taken twice daily with meals Receives: Dietary Supplement: apple cider vinegar |
| vinegar pill | Placebo comparator | 1 vinegar pill taken daily Receives: Dietary Supplement: vinegar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
mood state
Profile of Mood States (POMS) questionnaire score
Measured: change from baseline at day 28
depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: change from baseline at day 28
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 start29 Sep 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706806
- Sponsor's protocol ID
- STUDY00012406
- Acronym
- VIN2020
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 13 Jan 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 13 Jan 2021. 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 in Healthy College Students
- ClinicalTrials.gov ID
- NCT04706806
- Acronym / sponsor ID
- VIN2020 / STUDY00012406
- Conditions
- Mood, Depression
- Keywords
- acetic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (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.
The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion.
Detailed description
Recent research suggests that fruit and vegetable intake is inversely associated with mood states and depression. Although the mechanism is not known, increased gut fermentation is suspected as changes in gut tryptophan metabolism was noted in these trials. Tryptophan is the precursor to serotonin, the neurotransmitter associated with improved mood state, but other metabolites of tryptophan have been associated with mental wellbeing as well. The main ingredient of vinegar, acetic acid, is the most common metabolite produced during gut fermentation of dietary fiber (mainly from fruits and vegetables) and can also be expected to influence the gut microbiome. It has been reported that vinegar ingestion is linked to a change in tryptophan metabolism in healthy adults consuming vinegar daily for 8 weeks. This study will explore the impact of vinegar ingestion on mood states.
Study design
- Primary purpose
- Supportive care
- 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: apple cider vinegar2 tablespoons (diluted in water) taken twice daily with meals |
| vinegar pill | Placebo comparator | Dietary Supplement: vinegar pill1 vinegar pill taken daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- college student, non-athlete, no chronic health condition
Key exclusion criteria (1 listed)
- vegetarians or others adhering to special diet, body mass index >30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar
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 |
|---|---|---|
| apple cider vinegarAlso: apple cider vinegar (Bragg Live Food Products, LLC)2 tablespoons diluted in water taken twice daily with meals | Dietary supplement | liquid vinegar |
| vinegar pillAlso: Nature's Bounty Apple Cider Vinegar pillsone pill taken daily | Dietary supplement | vinegar pill |
Primary outcome
mood state
Time frame: change from baseline at day 28
Profile of Mood States (POMS) questionnaire score
depression
Time frame: change from baseline at day 28
Center for Epidemiologic Studies Depression Scale (CES-D)
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 13 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apple cider vinegar and vinegar pill in people with Mood and Depression, 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 1 inclusion and 1 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 13 Jan 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 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?
mood state (time frame: change from baseline at day 28). The study lists 2 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 13 Jan 2021.