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Grape Impact on Human Gut Microbiome
Sponsor: Icahn School of Medicine at Mount Sinai
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
Grape Powder
72 g of grape powder for daily consumption for 28 days.
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