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RECRUITING

NCT05545865

Chardonnay Marc and Vascular Response

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

Official title: Preclinical Trials to Determine the Range of Chardonnay Mark Intake for Improved Metabolic and Vascular Response.

Key Details

Gender

MALE

Age Range

30 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-09-01

Completion Date

2026-08-24

Last Updated

2026-02-18

Healthy Volunteers

Yes

Conditions

Cardiovascular Diseases Vascular Dilation Oxidative Stress

Interventions

OTHER

Low Flavanol Cocoa Powder

Measure the response 2 and 6 hours post low flavanol cocoa intake

OTHER

High Flavanol Cocoa Powder

Measure the response 2 and 6 hours post high flavanol cocoa intake

OTHER

Vine to Bar Chocolate - 2 servings

Measure the response 2 and 6 hours post chocolate intake

OTHER

Vine to Bar Chocolate - 1 serving

Measure the response 2 and 6 hours post chocolate intake

OTHER

Vine to Bar Chocolate covered almonds

Measure the response 2 and 6 hours post chocolate covered almond intake

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.

Locations (1)

Academic Surge, University of California, Davis

Davis, California, United States

Clinical Research Directory

Chardonnay Marc and Vascular Response

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)