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

NCT07214428 | Active Not Recruiting

• 1 other identifier: Pro2025001394
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota; Psychological Distress

Keywords

Table grape; Gut Microbiota; psychological distress

Outcome Measures

Primary Outcomes (3)

• Hamilton Anxiety Scale -14

  HAMA-14 is one of the earliest and most widely used clinical scales for measuring the severity of a patient's anxiety. It has 14 items, each reflecting a cluster of anxiety symptoms. Total range: 0 to 56, with higher scores indicating greater severity of anxiety

  baseline (1st), week 4 (2nd) and week 5 (3rd)

• 17-item of Hamilton Depression Rating Scale

  HAMD-17 is one of the most widely used clinician-administered scales for measuring the severity of a patient's depression. It has 17 items, each covering symptoms of depression across mood, physical, and cognitive domains. With higher scores indicating greater severity of depression.

  baseline (1st), week 4 (2nd) and week5 (3rd)

• 10-item of Perceived Stress Scale

  PSS-10 is one of the most widely used psychological instruments for measuring the perception of stress. It has 10 items, each reflecting how unpredictable, uncontrollable, and overloaded respondents find their lives during the past month. Total range: 0 to 40, with higher scores indicating greater perceived stress.

  baseline (1st), week 4 (2nd) and week5 (3rd)

Secondary Outcomes (3)

• Shannon Index of gut microbiota

  baseline (1st), week 4 (2nd) and week5 (3rd)

• Beta diversity of gut microbiota

  baseline (1st), week 4 (2nd) and week 5 (3rd)

• fecal short chain fatty acid

  baseline (1st), week 4 (2nd) and week5 (3rd)

Study Arms (2)

freeze-dried table grape powder (FTGP)

EXPERIMENTAL

Drink a daily supplement containing FTGP for 4 weeks

Dietary Supplement: freeze-dried table grape powder

Placebo

PLACEBO COMPARATOR

Drink a daily supplement containing a placebo for 4 weeks

Dietary Supplement: Placebo

Interventions

freeze-dried table grape powder DIETARY_SUPPLEMENT

48g freeze-dried table grape powder/day for 4 weeks

freeze-dried table grape powder (FTGP)

Placebo DIETARY_SUPPLEMENT

48g placebo/day for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• California Table Grape Commission: collaborator

Study Sites (1)

Department of Biochemistry and Microbiology, School of Environmental and Biological Sciences, Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Study Officials

• Guojun Wu

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start: October 20, 2025
• Primary Completion: December 24, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)