Chardonnay Marc for Cardiovascular Health

Overseen By Roberta R Holt

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anticoagulants, NSAIDs, Supplements

Disqualifiers: Diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants stop taking any prescription drugs or supplements, including herbal and plant supplements, at least a month before joining the study.

Is Chardonnay Marc safe for human use?

Research on cocoa flavanols, which are similar to those in Chardonnay Marc, suggests they are generally safe for human consumption. Studies have shown benefits for heart health, like improved blood pressure and blood vessel function, without significant safety concerns. ^{1 2 3 4 5}

How does the treatment 'Chardonnay Marc for Cardiovascular Health' differ from other treatments for cardiovascular conditions?

Chardonnay Marc for Cardiovascular Health is unique because it likely contains flavonoids, similar to those found in cocoa, which have been shown to improve cardiovascular health by enhancing blood vessel function and reducing blood pressure. Unlike traditional medications, this treatment may offer a natural alternative by utilizing plant-based compounds. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment involving cocoa and chocolate products for cardiovascular health?

Research shows that cocoa flavanols can improve heart health by lowering blood pressure, improving blood vessel function, and reducing the risk of heart-related events like heart attacks. Consuming flavanol-rich cocoa products has been associated with these benefits, suggesting that the treatment may help improve cardiovascular health. ^{1 2 4 6 8}

Who Is on the Research Team?

Carl L Keen

Principal Investigator

Distinguished Professor Emeritus of Nutrition

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 25-35 who have poor vascular response (RHI < 2.0) and can follow the study plan. It's not for heavy chocolate eaters, those with certain health conditions like heart disease or anemia, people taking blood thinners or supplements, vegans/vegetarians, or anyone allergic to nuts, cocoa, grapes.

Inclusion Criteria

BMI 25.0 - 35 kg/m2

Screening or Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) < 2.0

Subject is willing and able to comply with the study protocols

Exclusion Criteria

Current enrollee in a clinical research study

Blood pressure ≥ 140/90 mm Hg

BMI ≥ 35 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acute Intervention

Participants consume the study products and are monitored for postprandial response over 6 hours

6 hours

Follow-up

Participants are monitored for safety and effectiveness after the acute intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• High Flavanol Cocoa Powder
• Low Flavanol Cocoa Powder
• Vine to Bar Chocolate - 1 serving
• Vine to Bar Chocolate - 2 servings
• Vine to Bar Chocolate covered almonds

Trial Overview The study tests how different Vine to Bar products containing Chardonnay marc affect heart health and gut bacteria. Participants will try low/high flavanol cocoa powder and various servings of chocolate to see if there are benefits after 6 hours—longer than past studies on cocoa flavanols.

How Is the Trial Designed?

Group I: Vine to Bar Chocolate covered Almonds Experimental Treatment 2 Interventions

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

Group II: Two Servings of Vine to Bar Chocolate Experimental Treatment 2 Interventions

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

Group III: One Serving of Vine to Bar Chocolate Experimental Treatment 4 Interventions

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

Group IV: High Flavanol Cocoa Powder Experimental Treatment 4 Interventions

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

Group V: Low Flavanol Cocoa Powder Placebo Group 3 Interventions

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Regular consumption of flavanol-rich cocoa products can significantly lower systolic blood pressure, with a study showing a mean reduction of 5.8 mmHg in a population with mild hypercholesterolemia.

Human dietary intervention trials indicate that flavanol-containing foods, like cocoa, improve endothelial and platelet function, supporting their potential cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cocoa flavanols on risk factors for cardiovascular disease. Erdman, JW., Carson, L., Kwik-Uribe, C., et al.[2008]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Blood pressure and cardiovascular risk: what about cocoa and chocolate? [2013]

2. England pubmed.ncbi.nlm.nih.gov

The Impact of Cocoa Flavanols on Cardiovascular Health. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Effects of cocoa flavanols on risk factors for cardiovascular disease. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Cocoa Flavanol Cardiovascular Effects Beyond Blood Pressure Reduction. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Cacoa and dark chocolate in cardiovascular prevention?]. [2013]

6. Japan pubmed.ncbi.nlm.nih.gov

Flavan 3-ols improve metabolic syndrome risk factors: evidence and mechanisms. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Lack of acute or chronic effects of epicatechin-rich and procyanidin-rich apple extracts on blood pressure and cardiometabolic biomarkers in adults with moderately elevated blood pressure: a randomized, placebo-controlled crossover trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Flavonoid-rich dark chocolate improves endothelial function and increases plasma epicatechin concentrations in healthy adults. [2022]