Status:
RECRUITING
Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
California Table Grape Commission
Conditions:
Arterial Stiffness
Blood Pressure
Eligibility:
All Genders
45-70 years
Phase:
NA
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 an...
Detailed Description
Participants will limit intake of grapes and other polyphenol-rich foods while following their usual diet during the 1-week run-in period before the start of the intervention. They will be randomized ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06544954
Start Date
December 2 2024
End Date
January 1 2026
Last Update
April 24 2025
Active Locations (1)
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1
Ragle Human Nutrition Center
Davis, California, United States, 95616