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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorUniversity of California, Davis

About this trial

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

Eligibility criteria

Qualifiers

post-menopausal women (cessation of menstruation for minimum two years)

overweight and obese (BMI between 25-35 kg/m2)

stable treatment for type 2 diabetes or metabolic syndrome

ability to understand the intervention concept and written consent to participate

Disqualifiers

menopausal hormone replacement therapy started within less than 6 months

antibiotics, prebiotics within last 3 months

antidiabetic treatment involving insulin (for type 1 diabetes)

vegetarian/vegan and not able to follow modified diet

Trial design

Treatments tested in this trial

  • Freeze-dried grape powder
  • Placebo powder

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Davis

Lead sponsor

California Table Grape Commission

Collaborator