Clinical trial
Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
Recruiting now · Not applicable · 1 countries · Registry ID NCT06544954
What this study is about
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
Basic eligibility
Full registry criteria
Treatments and study arms
Freeze-dried grape powder
48 grams powder
Placebo powder
48 grams powder
Primary outcomes
Pulse Wave Velocity (PWV) from carotid to femoral artery after 5 minutes rest; PWV is an established index of aortic stiffness using a validated non-invasive device that allows online pulse wave recording and automatic PWV calculation
Average of latter 2 of 3 total measures (5 minutes apart) after 15 minutes of rest in a quiet room; SphygmoCor XCEL device will be used with participants in the seated position
16S rRNA sequencing of stool samples collected by participants from home in fecal collection tubes filled with DNA/RNA shield
ELISA (zonulin, LPS, LBP, sCD14, DAO) to assay fasted blood samples collected when participants visit the clinic
Luminex - Th17 inflammatory cytokines of fasted blood samples collected when participants visit the clinic
Lipid panel, comprehensive metabolic panel of fasted blood samples collected when participants visit the clinic
Study locations
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