Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of eating California grapes on gut health and heart-related issues in overweight men and women aged 45-70. Researchers want to find out if consuming grape powder can change the bacteria in the gut, improve gut health, and positively affect factors related to heart and metabolic health, such as inflammation and blood pressure. Participants will take grape powder mixed with water twice a day for three weeks while following their usual diet, with some adjustments to limit certain foods. They will also need to provide stool and blood samples and visit the clinic at the start and end of the study for tests.

To be eligible for this study, participants should be post-menopausal women or overweight/obese men and women with a body mass index (BMI) between 25 and 35. They should also have stable conditions like type 2 diabetes or metabolic syndrome but not be on certain medications or have serious health issues. Throughout the trial, participants will follow simple guidelines and will be monitored closely to see how grape consumption impacts their health. This study could help us understand the connection between gut health and overall well-being.

Gender

ALL

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