Chardonnay Marc and Vascular Response

Not Applicable

Recruiting

• Conditions: Vascular Dilation; Cardiovascular Diseases; Oxidative Stress
• Interventions: Other: Low Flavanol Cocoa Powder; Other: Vine to Bar Chocolate - 2 servings; Other: High Flavanol Cocoa Powder; Other: Vine to Bar Chocolate - 1 serving; Other: Vine to Bar Chocolate covered almonds

• Registration Number: NCT05545865
• Lead Sponsor: University of California, Davis

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-08-24
• Study Completion: 2025-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Flavanol Cocoa Powder	Low Flavanol Cocoa Powder	High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.
Low Flavanol Cocoa Powder	Vine to Bar Chocolate - 1 serving	12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water
High Flavanol Cocoa Powder	Vine to Bar Chocolate - 2 servings	High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.
One Serving of Vine to Bar Chocolate	High Flavanol Cocoa Powder	A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
High Flavanol Cocoa Powder	Vine to Bar Chocolate covered almonds	High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.
High Flavanol Cocoa Powder	Vine to Bar Chocolate - 1 serving	High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.
Two Servings of Vine to Bar Chocolate	Vine to Bar Chocolate covered almonds	Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
Low Flavanol Cocoa Powder	Vine to Bar Chocolate - 2 servings	12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water
Low Flavanol Cocoa Powder	High Flavanol Cocoa Powder	12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water
One Serving of Vine to Bar Chocolate	Low Flavanol Cocoa Powder	A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
Two Servings of Vine to Bar Chocolate	Vine to Bar Chocolate - 1 serving	Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
One Serving of Vine to Bar Chocolate	Vine to Bar Chocolate - 2 servings	A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
Vine to Bar Chocolate covered Almonds	Vine to Bar Chocolate - 2 servings	11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds
One Serving of Vine to Bar Chocolate	Vine to Bar Chocolate covered almonds	A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc.
Vine to Bar Chocolate covered Almonds	Vine to Bar Chocolate - 1 serving	11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds

Primary Outcome Measures

Name	Time	Method
Framingham Reactive Hyperemia Index (fRHI)	6 hours	measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000)

Secondary Outcome Measures

Name	Time	Method
Platelet aggregation	6 hours	Platelet aggregation after collagen activation will be assessed using platelet aggregometry
Total nitrate	6 hours	circulating levels of nitrate
soluble NADPH oxidase	6 hours	measure of oxidative stress
Insulin	6 hours	Serum insulin levels will be measured
Glucose	6 hours	Plasma glucose will be measured

Trial Locations

Locations (1)

Academic Surge, University of California, Davis; 🇺🇸 Davis, California, United States