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NOT YET RECRUITING
NCT07797803
NA

Grape Impact on Human Gut Microbiome

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Official title: High-Resolution Assessment of California Table Grape Consumption on the Human Gut Microbiome-Immune Axis

Key Details

Gender

All

Age Range

45 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10

Completion Date

2027-02

Last Updated

2026-09-24

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States