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

NCT ID: NCT07214428

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2026-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gut Microbiota Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

freeze-dried table grape powder (FTGP)

Drink a daily supplement containing FTGP for 4 weeks

Group Type EXPERIMENTAL

freeze-dried table grape powder

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Drink a daily supplement containing a placebo for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

48g placebo/day for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

freeze-dried table grape powder

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

48g placebo/day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Table Grape Commission

OTHER

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guojun Wu, Ph.D.

Assistant Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guojun Wu

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

New Brunswick, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro2025001394

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotics in Functional Dyspepsia
NCT07276009 NOT_YET_RECRUITING NA