Grape Impact on Human Gut Microbiome

Conditions

• Gut Microbiomes

Eligibility Criteria

Sex

ALL

Age

45 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Grape Powder — DIETARY_SUPPLEMENT
  72 g of grape powder for daily consumption for 28 days.
• Placebo Powder — OTHER
  72 g of matching placebo for daily consumption for 28 days.

Study Details

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.

Key Dates

First listed

Sep 1, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Grape Powder
  Receive grape powder for consumption during intervention stage.
• Placebo Comparator: Control
  Receive placebo control powder for consumption during intervention stage.

Primary Outcome Measure

Long read sequencing [ Time Frame: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet) ]

Central Contacts

• Gang Fang, PhD
  212-659-1570
  [email protected]
• Edward A Mead, PhD
  212-659-6844
  [email protected]

Locations (1)

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