Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students (NCT07214428) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students
United States50 participantsStarted 2025-10-20
Plain-language summary
The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are:
Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota.
Participants will:
Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18-30 years old
* Able to give written informed consent.
* BMI 18.5-24.9 kg/m2
* Healthy (self-reported)
* Can read and speak English
Exclusion Criteria:
* Currently taking medications that interfere with polyphenol
* Currently using or have used antibiotics continuously for \>3 days within 3 months prior to enrollment
* Have had surgery involving the intestinal lumen within the last 30 days
* Have a documented diagnosis of celiac disease or/and inflammatory bowel diseases
* Are pregnant or breastfeeding
* Have prediabetes and diabetes
* Have had bariatric surgery
* Are immunocompromised ( e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, or poorly controlled HIV/AIDS)
* Are unable to provide consent
* Are hospitalized,
* Have a history of or current alcohol, drug, or medication abuse (self-reported),
* Have contraindication to any substance in the investigational product or who are currently enrolled in other interventional trials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton Anxiety Scale -14
Timeframe: baseline (1st), week 4 (2nd) and week 5 (3rd)
2
17-item of Hamilton Depression Rating Scale
Timeframe: baseline (1st), week 4 (2nd) and week5 (3rd)
3
10-item of Perceived Stress Scale
Timeframe: baseline (1st), week 4 (2nd) and week5 (3rd)
Trial details
NCT IDNCT07214428
SponsorRutgers, The State University of New Jersey