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Grape Impact on Human Gut Microbiome

NCT07797803 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-01

No results posted yet for this study

Summary

This is a bio-specimen analysis and dietary intervention study that will examine whether the daily consumption of California table grape powder significantly modulates the gut microbiome and systemic immune profiles in healthy adults. The primary objective is to characterize longitudinal changes in microbial strains, metabolites, and immune markers following a 4-week grape intervention compared to a placebo. Methods include a screening of up to 300 individuals to evaluate pre-specified microbiome eligibility criteria, followed by a randomized, double-blind, placebo-controlled, parallel-group design where up to 40 participants will provide fecal and blood samples for high-resolution metagenomic sequencing and LC-MS/MS metabolomics at baseline, mid-study, and post-washout. Participants who meet the microbiome screening and other study eligibility criteria may be invited to participate in the intervention phase; participation in the screening phase does not guarantee enrollment in the intervention phase.

Conditions

  • Gut Microbiomes

Interventions

DIETARY_SUPPLEMENT

Grape Powder

72 g of grape powder for daily consumption for 28 days.

OTHER

Placebo Powder

72 g of matching placebo for daily consumption for 28 days.

Sponsors & Collaborators

Principal Investigators

  • Gang Fang, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797803 on ClinicalTrials.gov