Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06544954

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 70 Years
SexAll
Healthy volunteersAccepted
ConditionArterial Stiffness, Blood Pressure, Dysbiosis, Inflammation, Permeability; Increased

Full registry 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

Treatments and study arms

Freeze-dried grape powder

Dietary Supplement

48 grams powder

Placebo powder

Other

48 grams powder

Primary outcomes

Arterial stiffness Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

Pulse Wave Velocity (PWV) from carotid to femoral artery after 5 minutes rest; PWV is an established index of aortic stiffness using a validated non-invasive device that allows online pulse wave recording and automatic PWV calculation

Blood pressure Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

Average of latter 2 of 3 total measures (5 minutes apart) after 15 minutes of rest in a quiet room; SphygmoCor XCEL device will be used with participants in the seated position

Gut microbiome composition Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

16S rRNA sequencing of stool samples collected by participants from home in fecal collection tubes filled with DNA/RNA shield

Gut permeability markers Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

ELISA (zonulin, LPS, LBP, sCD14, DAO) to assay fasted blood samples collected when participants visit the clinic

Systemic inflammatory markers Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

Luminex - Th17 inflammatory cytokines of fasted blood samples collected when participants visit the clinic

Lipid and metabolic profiles Change from BaselineBaseline (Visit 1), Week 3 (Visit 2), Week 9 (Visit 4)

Lipid panel, comprehensive metabolic panel of fasted blood samples collected when participants visit the clinic

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Ragle Human Nutrition Center🇺🇸 Davis, California, United States
Jody RandolphContact
Dragan Milenkovic, PhDPrincipal Investigator
Francene M Steinberg, PhD, RDPrincipal Investigator