Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students

Rutgers The State University of New Jersey

Status: Active, not recruiting

Conditions: Gut Microbiota; Psychological Distress

Treatments: Dietary Supplement: freeze-dried table grape powder; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07214428

Pro2025001394

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

freeze-dried table grape powder (FTGP)

Experimental group

Description:

Drink a daily supplement containing FTGP for 4 weeks

Treatment:

Dietary Supplement: freeze-dried table grape powder

Placebo

Placebo Comparator group

Description:

Drink a daily supplement containing a placebo for 4 weeks

Treatment:

Dietary Supplement: Placebo