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Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women

NCT06544954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome, intestinal permeability, systemic inflammation, and vascular function in healthy overweight men and women aged 45-70 years. The main questions it aims to answer are:

* Does daily grape intake alter intestinal microbiome composition and intestinal permeability?
* Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors (inflammation, vascular function, lipid profiles)?
* Does response to grape intake on gut microbiota, intestinal permeability, cardiometabolic and inflammatory markers differ between men and women?
* Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors?

Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors.

Participants will

* Consume the powder dissolved in water twice daily for 3 weeks
* Follow their usual diet, modified to limit polyphenol-rich foods
* Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection
* Complete a 3-day 24-hour dietary recall and collect stool sample before each visit

Conditions

Interventions

DIETARY_SUPPLEMENT

Freeze-dried grape powder

48 grams powder

OTHER

Placebo powder

48 grams powder

Sponsors & Collaborators

  • California Table Grape Commission

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2026-11-30
Completion
2027-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06544954 on ClinicalTrials.gov