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

Part of paid clinical trials in Davis, California.

Sponsor
University of California, Davis
Study ID
NCT06544954
Status
Recruiting
Apply to this trial

Conditions

  • Arterial Stiffness
  • Blood Pressure
  • Dysbiosis
  • Inflammation
  • Permeability; Increased

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Freeze-dried grape powder — DIETARY_SUPPLEMENT
    48 grams powder
  • Placebo powder — OTHER
    48 grams powder

Study Details

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

Key Dates

Start date
May 7, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Grape, Then Placebo
    Participants consume 48 grams of freeze-dried grape powder (dissolved into water) twice daily for 3 weeks. After a washout period of at least 3 weeks, participants then consume 48 grams of placebo powder matching grape powder (dissolved into water) twice daily for 3 weeks.
  • Experimental: Placebo, Then Grape
    Participants consume 48 grams of placebo powder matching grape powder (dissolved into water) twice daily for 3 weeks. After a washout period of at least 3 weeks, participants then consume 48 grams of freeze-dried grape powder (dissolved into water) twice daily for 3 weeks.

Primary Outcome Measure

Arterial stiffness Change from Baseline [ Time Frame: Baseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ragle Human Nutrition CenterDavisCalifornia95616
Jody Randolph
[email protected]
530-752-7620
Dragan Milenkovic, PhD (PRINCIPAL_INVESTIGATOR)
Francene M Steinberg, PhD, RD (PRINCIPAL_INVESTIGATOR)
Shannon H Trinh, MS, RD (SUB_INVESTIGATOR)

Find similar trials in Davis, CA

By research site
Ragle Human Nutrition Center· Davis, CA

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