- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04706806
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students (VIN2020)
January 11, 2021 updated by: Carol Johnston, Arizona State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- college student, non-athlete, no chronic health condition
Exclusion Criteria:
- vegetarians or others adhering to special diet, body mass index >30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: liquid vinegar
2 tablespoons (diluted in water) taken twice daily with meals
|
2 tablespoons diluted in water taken twice daily with meals
Other Names:
|
|
Placebo Comparator: vinegar pill
1 vinegar pill taken daily
|
one pill taken daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mood state
Time Frame: change from baseline at day 28
|
Profile of Mood States (POMS) questionnaire score
|
change from baseline at day 28
|
|
depression
Time Frame: change from baseline at day 28
|
Center for Epidemiologic Studies Depression Scale (CES-D)
|
change from baseline at day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2020
Primary Completion (Actual)
November 17, 2020
Study Completion (Actual)
November 17, 2020
Study Registration Dates
First Submitted
January 11, 2021
First Submitted That Met QC Criteria
January 11, 2021
First Posted (Actual)
January 13, 2021
Study Record Updates
Last Update Posted (Actual)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00012406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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