Icahn School of Medicine at Mount Sinai
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.
The human gut microbiome consists of trillions of microorganisms that are essential to host metabolism, immune system regulation, and the maintenance of disease resistance. Recent findings indicate that dietary changes can rapidly and significantly alter the composition of these microbial communities, leading to substantial effects on the host's overall physiology. Foods rich in polyphenols are highly effective at modulating this environment because they possess selective antimicrobial properties and exert beneficial prebiotic effects on the resident microbiota. Polyphenol-rich foods benefici…
Inclusion Criteria * Healthy adults between the ages of 45 and 65 years old * Body Mass Index (BMI) within the range of 18.5 to 25.9 kg/m² * Willing and able to provide informed consent * Agreement to maintain usual dietary patterns throughout the study, except for the provided study powder * Agreement to avoid exclusion criteria (below) during the study period * Able and willing to collect and mail a stool sample during the microbiome screening phase and, if enrolled in the intervention phase, and at the three defined study timepoints * For enrollment into the intervention phase, meeting pre…
72 g of grape powder for daily consumption for 28 days.
72 g of matching placebo for daily consumption for 28 days.
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