Effects of Chardonnay marc on heart health
Preclinical Trials to Determine the Range of Chardonnay Mark Intake for Improved Metabolic and Vascular Response.
This study is testing whether eating products made with Chardonnay marc can improve heart health and how our bodies respond after meals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 30 Years to 50 Years |
| Sex | Male |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT05545865 on ClinicalTrials.gov |
What this trial studies
This study investigates how products containing Chardonnay marc may influence cardiometabolic health by examining the postprandial vascular response in individuals. Participants will consume various cocoa products, and their responses will be monitored over a 6-hour period to assess the impact on vascular function and gut microbiome biomarkers. The study employs a crossover design with a small group of participants to minimize variability and ensure accurate data collection. The findings will inform future dietary intervention trials focused on the health benefits of Chardonnay marc.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 25.0 and 35 kg/m2 who have a Reactive Hyperemia Index (RHI) of less than 2.0.
Not a fit: Patients with a BMI of 35 kg/m2 or higher, those with certain blood conditions, or individuals with allergies to cocoa or grape products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve cardiovascular health through the consumption of Chardonnay marc.
How similar studies have performed: While there is limited data on the specific effects of Chardonnay marc, similar studies on cocoa flavanols have shown promising results in improving vascular function.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Screening or Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) \< 2.0 * Subject is willing and able to comply with the study protocols. * Subject is willing to participate in all study procedures * BMI 25.0 - 35 kg/m2 Exclusion Criteria: * BMI ≥ 35 kg/m2 * Indivduals that weight less than a 110 lbs * Donation of blood within the previous 30 days * Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.0 * 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%. * Platelet counts \< 150,000 / ul * Anemia, which includes self report, or a screening hemoglobin and hematocrit that is less than the normal reference range or as diagnosed by study physician upon review of complete blood cell count reports. * Dislike or allergy for nuts, cocoa or grape products * Self-reported use of daily anticoagulation agents including aspirin, NSAIDs * Vegan, Vegetarians, food faddists or those consuming a non-traditional diet * Fruit consumption ≥ 3 cups/day * Vegetable consumption ≥ 4 cups/day * Nut intake ≥ 2 servings/ week * 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 * Self-reported diabetes * Blood pressure ≥ 140/90 mm Hg * Self-reported renal or liver disease * Self-reported heart disease, which includes cardiovascular events and stroke * Peripheral artery disease, Raynaud's syndrome * 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 malabsorption * Currently taking prescription drugs or supplements. * Supplement use or unwillingness to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment. * Indications of substance or alcohol abuse within the last 3 years * smoking, vaping, cannabis use * Current enrollee in a clinical research study.
Where this trial is running
Davis, California
- Academic Surge, University of California, Davis — Davis, California, United States (Recruiting)
Study contacts
- Principal investigator: Carl L Keen — Distinguished Professor Emeritus of Nutrition
- Study coordinator: Roberta R Holt
- 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.