Effects of Chardonnay Marc on gut and heart health
The Influence of Chardonnay Marc Intake on Gut and Cardiometabolic Health
NA · University of California, Davis · NCT06476795
This study is testing if adding Chardonnay grape skins and seeds to the diet can improve gut and heart health in obese postmenopausal women.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | Female |
| Sponsor | University of California, Davis (other) |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT06476795 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of incorporating Chardonnay Marc, the skins and seeds of Chardonnay grapes, into the diet on gut and cardiometabolic health. Participants will consume varying amounts of Chardonnay Marc powder daily for 12 weeks, with assessments conducted at baseline, 6 weeks, and 12 weeks. The study aims to collect pilot data on changes in gut permeability, inflammation, and cardiometabolic markers in obese postmenopausal women. Participants will log their intake and how they incorporate the Marc into their meals.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 45-70 with a BMI between 31-49.9 kg/m2 and elevated fasting triglycerides.
Not a fit: Patients who are on anticoagulants, have certain chronic health conditions, or follow restrictive diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve gut and cardiovascular health in obese individuals.
How similar studies have performed: While the specific use of Chardonnay Marc is novel, similar dietary interventions with flavanol-rich foods have shown promise in improving cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal female, with a cessation of menses for at least 2 years * 45-70 years of age * BMI 25- 49.9 kg/m2 * Fasting triglycerides \> 120 mg/dL * Subject is willing and able to comply with the study protocols and procedures. Exclusion Criteria: * Self-reported use of daily anticoagulation agents including aspirin, NSAIDs * Prescription medications and supplements, except for a 6 month stable dose of thyroid medications * Vegan, Vegetarians, food faddists or those consuming a non-traditional diet * Fruit consumption ≥ 3 cups/day * Vegetable consumption ≥ 4 cups/day * Coffee/tea ≥ 3 cups/day * Dark chocolate ≥ 3 oz/day * Self-reported restriction of physical activity due to a chronic health condition * Self-reported chronic/routine high intensity exercise * Blood pressure ≥ 140/90 mm Hg * Self-reported renal or liver disease * Self-reported heart disease, which includes cardiovascular events and stroke, diabetes * Peripheral artery disease Raynaud's syndrome or disease * Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT * Self-reported cancer within past 5 years * Self-reported gastrointestinal disorders, apart from appendix removal * Unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements six weeks prior to study enrollment. * Indications of substance or alcohol abuse within the last 3 years * All forms of smoking (e.g. vaping, cigarette, cannabis) * Current enrollee in a clinical research study.
Where this trial is running
Davis, California
- University of California, Davis — Davis, California, United States (RECRUITING)
Study contacts
- Study coordinator: Roberta R Holt, PhD
- Email: rrholt@ucdavis.edu
- Phone: 5304005952
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.
Conditions: Cardiovascular Diseases, Adiposity, Cardiometabolic Syndrome