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Active Not Recruiting
NCT07214428
Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students
Conditions: Gut Microbiota, Psychological Distress
Sex: All
Ages: 18 Years – 30 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Rutgers, The State University of New Jersey
Location: Department of Biochemistry and Microbiology, School of Environmental and Biological Sciences, Rutgers, The State University of New Jersey New Brunswick New Jersey
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07214428). StuddyBuddy aggregates publicly available trial information.