RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-20
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06544954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * post-menopausal women (cessation of menstruation for minimum two years)
  2. * overweight and obese (BMI between 25-35 kg/m2)
  3. * stable treatment for type 2 diabetes or metabolic syndrome
  4. * ability to understand the intervention concept and written consent to participate
  5. * willingness to accept randomization, undergo testing and intervention procedures, and deliver stool and blood samples
  1. * menopausal hormone replacement therapy started within less than 6 months
  2. * antibiotics, prebiotics within last 3 months
  3. * antidiabetic treatment involving insulin (for type 1 diabetes)
  4. * vegetarian/vegan and not able to follow modified diet
  5. * 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
  6. * psychiatric disease that interferes with the understanding and implementation of the intervention
  7. * history of eating disorders such as bulimia nervosa, anorexia nervosa, severe binge eating disorder in the last 5 years
  8. * history of substance abuse or alcohol abuse
  9. * involvement in a weight loss intervention program (including anti-obesity medication) within last 3 months or have had bariatric surgery
  10. * current smokers (within last 180 days)
  11. * use of dietary supplements containing polyphenols in the past 1 month
  12. * strenuous exercise greater than 10 hours per week

Contacts and Locations

Study Contact

Dragan Milenkovic, PhD
CONTACT
(530) 219-5872
dmilenkovic@ucdavis.edu
Shannon H Trinh, MS, RD
CONTACT
(408) 802-9356
shtrinh@ucdavis.edu

Study Locations (Sites)

Ragle Human Nutrition Center
Davis, California, 95616
United States

Collaborators and Investigators

Sponsor: University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-20
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-03-20
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • gut microbiome
  • nutrition
  • cardiometabolic health

Additional Relevant MeSH Terms

  • Arterial Stiffness
  • Blood Pressure
  • Dysbiosis
  • Inflammation
  • Permeability; Increased