Chardonnay Marc and Vascular Response

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how a product made from Chardonnay grape leftovers, called Chardonnay marc, might affect heart and blood vessel health. Researchers want to better understand how this product influences health markers related to the heart and metabolism, as well as the gut bacteria that live in our digestive system. They are particularly interested in how people respond to this product over time, especially after consuming cocoa flavanols, which are natural compounds found in cocoa that can benefit blood vessel function.

To join this study, participants must be male adults aged between 18 and 65 with a body mass index (BMI) between 25 and 35. They should be generally healthy, not taking certain medications, and must not have specific health conditions like heart disease or diabetes. Participants will undergo a series of tests and will need to follow study guidelines, including dietary restrictions. This is an exciting opportunity for eligible individuals to contribute to research that could lead to new dietary recommendations for improving heart health!

Gender

MALE

Eligibility 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.