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Prebiotic

Freeze-dried grape powder for Arterial Stiffness (CALGRAM Trial)

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* post-menopausal women (cessation of menstruation for minimum two years)
* overweight (BMI between 25-30 kg/m2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 1), week 4 (visit 2), week 12 (visit 4)
Awards & highlights

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 4 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 dietary recall and collect stool sample before each visit

Who is the study for?
This trial is for healthy overweight men and women aged 45-70 who want to explore the health benefits of grape powder on gut and heart health. Participants should not have major health issues but may have concerns like high blood pressure or arterial stiffness. They must be willing to consume a test product daily and follow their usual diet with some restrictions.
What is being tested?
Researchers are testing if consuming freeze-dried grape powder can improve gut microbiome, intestinal permeability, inflammation levels, and vascular function compared to a placebo. The study involves taking the powder dissolved in water twice daily for four weeks while maintaining a normal diet with limited polyphenol-rich foods.
What are the potential side effects?
Since this trial involves food-based interventions (grape powder), side effects might be minimal but could include digestive discomfort or allergic reactions in rare cases. Any changes in bowel habits or unexpected symptoms will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 1), week 4 (visit 2), week 12 (visit 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 1), week 4 (visit 2), week 12 (visit 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Arterial stiffness Change from Baseline
Blood pressure Change from Baseline
Gut microbiome composition Change from Baseline
+3 more
Secondary study objectives
Global gene expression Change from Baseline
Gut permeability marker Change from Baseline
Metabolomics and Lipidomics Change from Baseline

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then GrapeExperimental Treatment2 Interventions
Participants consume 40 grams of placebo powder matching grape powder (dissolved into water) twice daily for 4 weeks. After a washout period of at least 4 weeks, participants then consume 40 grams of freeze-dried grape powder (dissolved into water) twice daily for 4 weeks.
Group II: Grape, Then PlaceboExperimental Treatment2 Interventions
Participants consume 40 grams of freeze-dried grape powder (dissolved into water) twice daily for 4 weeks. After a washout period of at least 4 weeks, participants then consume 40 grams of placebo powder matching grape powder (dissolved into water) twice daily for 4 weeks.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
924 Previous Clinical Trials
4,721,867 Total Patients Enrolled
California Table Grape CommissionOTHER
7 Previous Clinical Trials
227 Total Patients Enrolled
~27 spots leftby Mar 2026