RecruitingNot Applicable

Chardonnay Marc and Vascular Response

United States5 participantsStarted 2022-09-01

Plain-language summary

This study aims to obtain data on the potential influence of Vine to Bar product(s) containing Chardonnay marc on cardiometabolic health. These initial studies will inform the design and timing of data collection for future dietary intervention trials that will examine the influence of Chardonnay marc intake on outcomes/biomarkers of both cardiometabolic health and the gut microbiome. This includes collecting data on the potential differences in response to the products based on the unique food matrix for each of the products that will be tested. Moreover, as there is a paucity of data on the influence of cocoa flavanol intake on vascular function beyond 4 hours post intake, the response of the selected outcomes will be assessed after 6 hours of flavanol intake. This is a time point that captures the increased circulating presence of microbial derived flavanol metabolites.

Who can participate

Age range

30 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Framingham Reactive Hyperemia Index (fRHI)

Timeframe: 6 hours

Trial details

NCT IDNCT05545865

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-24

Contact for this trial

Roberta R Holt

5304005952 rrholt@ucdavis.edu

View on ClinicalTrials.gov More Cardiovascular Diseases trials