Effects of California grapes on gut and heart health in overweight adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how consuming freeze-dried grape powder affects gut microbiome, intestinal permeability, inflammation, and vascular function in healthy overweight men and women aged 45-70. Participants will follow a controlled diet and consume either grape powder or a placebo for three weeks, with assessments of gut health and cardiometabolic markers conducted before and after each intervention phase. The study aims to determine the relationship between grape intake and changes in gut health and cardiometabolic risk factors, while also exploring potential differences in responses between genders.

Why it matters

Who can join: the full rules

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

Where it's running

• Ragle Human Nutrition Center
  Davis, California, United States Recruiting

Study contacts

• Study coordinator: Dragan Milenkovic, PhD
• Email: dmilenkovic@ucdavis.edu
• Phone: (530) 219-5872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.