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NCT Number: NCT05545865

Chardonnay Marc and Vascular Response

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.

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Key information

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Academic Surge, University of California, Davis

Davis, California, 95616, United States

Location status: Recruiting

Location contact

Roberta R Holt, PhD

CONTACT

[email protected]

530-400-5952

About this study

The current set of trials will be of an acute (single intake, followed over 6 hours) that examines the postprandial response of individuals to the products. These preclinical trials will be conducted in the same individuals in an crossover design in order to limit individual variability, and keep the numbers small (5 individuals maximum), but still be able to assess the response to the different products.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Flavanol Cocoa Powder

Other

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

High Flavanol Cocoa Powder

Other

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

Vine to Bar Chocolate - 2 servings

Other

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate - 1 serving

Other

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate covered almonds

Other

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

Primary outcomes

  1. Framingham Reactive Hyperemia Index (fRHI)

    Time frame: 6 hours

    measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)

Secondary outcomes

  1. Platelet aggregation

    Time frame: 6 hours

    Platelet aggregation after collagen activation will be assessed using platelet aggregometry

  2. soluble NADPH oxidase

    Time frame: 6 hours

    measure of oxidative stress

  3. Glucose

    Time frame: 6 hours

    Plasma glucose will be measured

  4. Insulin

    Time frame: 6 hours

    Serum insulin levels will be measured

  5. Total nitrate

    Time frame: 6 hours

    circulating levels of nitrate

Study contacts

Contact information is provided by the study sponsor or research team.

Roberta R Holt

CONTACT

[email protected]

5304005952

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2022
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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