Chardonnay Marc and Vascular Response
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: High Flavanol Cocoa Powder
Cocoa Powder providing 435 mg of cocoa flavanols
Other: Vine to Bar Chocolate - 2 servings
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate - 1 serving
Chocolate providing both cocoa flavanols and Chardonnay marc
|
| Experimental: High Flavanol Cocoa Powder High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water. |
Other: Low Flavanol Cocoa Powder
Cocoa Powder providing 30 mg of cocoa flavanols
Other: Vine to Bar Chocolate - 2 servings
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate - 1 serving
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate covered almonds
Almonds covered with Vine to Bar Chocolate that provides both cocoa flavanols and Chardonnay marc
|
| 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. |
Other: Vine to Bar Chocolate - 1 serving
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate covered almonds
Almonds covered with Vine to Bar Chocolate that provides 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. |
Other: Low Flavanol Cocoa Powder
Cocoa Powder providing 30 mg of cocoa flavanols
Other: High Flavanol Cocoa Powder
Cocoa Powder providing 435 mg of cocoa flavanols
Other: Vine to Bar Chocolate - 2 servings
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate covered almonds
Almonds covered with Vine to Bar Chocolate that provides 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 |
Other: Vine to Bar Chocolate - 2 servings
Chocolate providing both cocoa flavanols and Chardonnay marc
Other: Vine to Bar Chocolate - 1 serving
Chocolate providing both cocoa flavanols and Chardonnay marc
|
Outcome Measures
Primary Outcome Measures
- Framingham Reactive Hyperemia Index (fRHI) [6 hours]
measurement of microvascular function using the EndoPAT 2000
Secondary Outcome Measures
- Platelet aggregation [6 hours]
Platelet aggregation after collagen activation will be assessed using platelet aggregometry
- soluble NADPH oxidase [6 hours]
measure of oxidative stress
- Glucose [6 hours]
Plasma glucose will be measured
- Insulin [6 hours]
Serum insulin levels will be measured
- Total nitrate [6 hours]
circulating levels of nitrate
Eligibility Criteria
Criteria
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 CBC 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Academic Surge, University of California, Davis | Davis | California | United States | 95616 |
Sponsors and Collaborators
- University of California, Davis
Investigators
- Principal Investigator: Carl L Keen, Distinguished Professor Emeritus of Nutrition
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1810396