NCT06544954 Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
| NCT ID | NCT06544954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Arterial Stiffness |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-07 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-05-07 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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 * willingness to accept randomization, undergo testing and intervention procedures, and deliver stool and blood samples Exclusion Criteria: * 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 * any serious medical condition including but not limited to coronary artery disease, uncontrolled hypertension, stroke, congestive heart failure, insulin-dependent diabetes, liver disease, active cancer and anemia * psychiatric disease that interferes with the understanding and implementation of the intervention * history of eating disorders such as bulimia nervosa, anorexia nervosa, severe binge eating disorder in the last 5 years * history of substance abuse or alcohol abuse * involvement in a weight loss intervention program (including anti-obesity medication) within last 3 months or have had bariatric surgery * current smokers (within last 180 days) * use of dietary supplements containing polyphenols in the past 1 month * strenuous exercise greater than 10 hours per week
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06544954 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 70 Years, studying Arterial Stiffness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06544954 currently recruiting?
Yes, NCT06544954 is actively recruiting participants. Contact the research team at dmilenkovic@ucdavis.edu for enrollment information.
Where is the NCT06544954 trial being conducted?
This trial is being conducted at Davis, United States.
Who is sponsoring the NCT06544954 clinical trial?
NCT06544954 is sponsored by University of California, Davis. The trial plans to enroll 40 participants.