Effects of California grapes on gut and heart health in overweight adults
Assessing Prebiotic Effect of California Grape Consumption on Gut Microbiome and Impact on Intestinal Permeability, Vascular Function, and Systemic Inflammation in Over-weight Subjects: Differences in Effects Between Men and Women
This study is testing whether eating freeze-dried grape powder can improve gut and heart health in overweight adults aged 45-70.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT06544954 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women and overweight men and women aged 45-70 with a BMI between 25-35.
Not a fit: Patients with serious medical conditions or those on specific medications that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve gut health and reduce cardiometabolic risks in overweight individuals.
How similar studies have performed: Other studies have shown promising results with dietary interventions targeting gut health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Davis, California
- Ragle Human Nutrition Center — Davis, California, United States (Recruiting)
Study contacts
- Study coordinator: Dragan Milenkovic, PhD
- Email: dmilenkovic@ucdavis.edu
- Phone: (530) 219-5872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.