Chardonnay Marc and Vascular Response

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, Vascular Dilation, Oxidative Stress

Intervention / Treatment
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* Other: Low Flavanol Cocoa Powder
* Other: High Flavanol Cocoa Powder
* Other: Vine to Bar Chocolate - 2 servings
* Other: Vine to Bar Chocolate - 1 serving
* Other: Vine to Bar Chocolate covered almonds


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Acute crossover design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low Flavanol Cocoa Powder<br>12 g of Low Flavanol Cocoa Powder (30 mg of cocoa flavanols) provided as a beverage mixed in water | Other: High Flavanol Cocoa Powder<br>* Measure the response 2 and 6 hours post high flavanol cocoa intake<br>Other: Vine to Bar Chocolate - 2 servings<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate - 1 serving<br>* Measure the response 2 and 6 hours post chocolate intake<br>|
| Experimental: High Flavanol Cocoa Powder<br>High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water. | Other: Low Flavanol Cocoa Powder<br>* Measure the response 2 and 6 hours post low flavanol cocoa intake<br>Other: Vine to Bar Chocolate - 2 servings<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate - 1 serving<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate covered almonds<br>* Measure the response 2 and 6 hours post chocolate covered almond intake<br>|
| Experimental: Two Servings of Vine to Bar Chocolate<br>Two servings (60g, 6 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc. | Other: Vine to Bar Chocolate - 1 serving<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate covered almonds<br>* Measure the response 2 and 6 hours post chocolate covered almond intake<br>|
| Experimental: One Serving of Vine to Bar Chocolate<br>A single serving (30g, 3 pieces) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc. | Other: Low Flavanol Cocoa Powder<br>* Measure the response 2 and 6 hours post low flavanol cocoa intake<br>Other: High Flavanol Cocoa Powder<br>* Measure the response 2 and 6 hours post high flavanol cocoa intake<br>Other: Vine to Bar Chocolate - 2 servings<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate covered almonds<br>* Measure the response 2 and 6 hours post chocolate covered almond intake<br>|
| Experimental: Vine to Bar Chocolate covered Almonds<br>11 pieces (45g) of Vine to Bar Chocolate providing both cocoa flavanols and Chardonnay marc, with almonds | Other: Vine to Bar Chocolate - 2 servings<br>* Measure the response 2 and 6 hours post chocolate intake<br>Other: Vine to Bar Chocolate - 1 serving<br>* Measure the response 2 and 6 hours post chocolate intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham Reactive Hyperemia Index (fRHI) | measurement of microvascular function using peripheral arterial tonometry (EndoPAT2000) | 6 hours | 

Secondary Outcome Measures

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