Recruiting

Chardonnay Marc

Sponsor:

UCLA

Code:

NCT05545865

Conditions

Cardiovascular Diseases

Vascular Dilation

Oxidative Stress

Eligibility Criteria

Sex: Male

Age: 30 - 50

Healthy Volunteers: Accepted

Interventions

Low Flavanol Cocoa Powder

High Flavanol Cocoa Powder

Vine to Bar Chocolate - 2 servings

Vine to Bar Chocolate - 1 serving

Vine to Bar Chocolate covered almonds

Study Details

Brief 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.

Conditions

Cardiovascular Diseases

Vascular Dilation

Oxidative Stress

Study ID

NCT05545865

Start date

Sep 1, 2022

Status verified date

Feb, 2026

Completion date

Aug 24, 2026

Anticipated

Primary completion date

Aug 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Low Flavanol Cocoa Powder

12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water

experimental: High Flavanol Cocoa Powder

High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.

experimental: Two Servings of Vine to Bar Chocolate

Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.

experimental: One Serving of Vine to Bar Chocolate

A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.

experimental: Vine to Bar Chocolate covered Almonds

11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds

Interventions

Low Flavanol Cocoa Powder

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

High Flavanol Cocoa Powder

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

Vine to Bar Chocolate - 2 servings

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate - 1 serving

Measure the response 2 and 6 hours post chocolate intake

Vine to Bar Chocolate covered almonds

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

Primary outcome measure

  • Framingham Reactive Hyperemia Index (fRHI) [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Roberta R Holt

5304005952rrholt@ucdavis.edu

Locations

Academic Surge, University of California, Davis

Recruiting

Davis, California, United States, 95616

Contacts

Roberta R Holt, PhD

530-400-5952rrholt@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-02-18.