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 trial explores how products containing Chardonnay marc (a by-product of wine production) might affect heart health and metabolism. Participants will consume various forms of chocolate and cocoa powder to assess their impact on heart and gut health markers. It suits individuals with a BMI between 25 and 35 who enjoy chocolate and do not follow restrictive diets or have chronic conditions like diabetes or heart disease. As an unphased trial, this study provides a unique opportunity to contribute to innovative research on heart health and metabolism.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the chocolate and cocoa powder under testing appear safe for people. Studies on dark chocolate, including those with Chardonnay marc, indicate they are generally well-tolerated. Although specific safety data for Vine to Bar products is limited, they are marketed as safe and sustainable, with no known safety issues.

For cocoa powder, research suggests that cocoa with high flavanol content is linked to fewer heart problems, implying it might be safe to consume. However, since this study is in its early stages, the safety evidence isn't as robust as it is for treatments studied longer.

In summary, while early findings suggest these products are safe, more research is needed to confirm their safety in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cardiovascular health, which often include medications like statins or lifestyle changes such as diet and exercise, the investigational treatments in this trial involve the use of cocoa flavanols and Chardonnay marc, derived from chocolate and wine byproducts. Researchers are excited because these treatments provide a unique combination of antioxidants and polyphenols that may support heart health in a delicious and enjoyable way. The inclusion of Chardonnay marc introduces a new source of polyphenols, which are not commonly found in traditional cardiovascular therapies. These natural compounds might offer heart benefits with fewer side effects and a more enjoyable experience for patients.

What evidence suggests that this trial's treatments could be effective for cardiometabolic health?

Research has shown that cocoa flavanols can help maintain heart health. Specifically, cocoa flavanols have been associated with a 27% decrease in deaths from heart-related diseases. Some studies suggest that eating chocolate might lower the risk of heart disease by up to 37%. In this trial, participants will receive different treatments, including Vine to Bar chocolate products containing Chardonnay marc. Chardonnay marc may improve blood vessel function and reduce oxidative stress, which is linked to aging and long-term illnesses. This combination of cocoa flavanols and Chardonnay marc could enhance the heart health benefits of these chocolate products. ^{3 6 7 8 9}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9170467/

Effect of cocoa flavanol supplementation for the prevention of ... Conclusions. Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%. Potential ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.125.25209

Long-Term Effect of Cocoa Extract Supplementation on ... Cocoa flavanols have potential blood pressure (BP)-lowering effects in shorter-term, smaller-scale randomized clinical trials, but their effect ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S027869152100154X

Impact of cocoa flavanols on human health A meta-analysis of seven observational studies (114,009 participants) showed that greater chocolate consumption was linked with a 37% lower risk of CVD and a 29 ...

4. uscjournal.com uscjournal.com/articles/cocoa-flavanols-and-cardiovascular-health?language_content_entity=en

Cocoa Flavanols and Cardiovascular Health | USC Journal This brief review will highlight the growing body of evidence that flavanol-rich cocoa may have a role in improving cardiovascular health.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165%2823%2902692-8/fulltext

Effects of chocolate, cocoa, and flavan-3-ols on cardiovascular ... We observed reductions in diastolic blood pressure (BP; −1.60 mm Hg; 95% CI: −2.77, −0.43 mm Hg) and mean arterial pressure (−1.64 mm Hg; 95% CI: −3.27, −0.01 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8031944/

Cocoa Flavanol Cardiovascular Effects Beyond Blood ... Epidemiological data in different patient cohorts revealed an association between higher intake of flavanol‐rich foods and decreased incidence of CV events, ...

7. fda.gov fda.gov/media/165090/download

Petition for a Qualified Health Claim – for Cocoa Flavanols ... health claims: “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that ...

8. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.108.827022

Cocoa and Cardiovascular Health | Circulation Epidemiological data demonstrate that regular dietary intake of plant-derived foods and beverages reduces the risk of coronary heart disease ...

9. uscjournal.com uscjournal.com/articles/cocoa-flavanols-and-cardiovascular-health-1?language_content_entity=en

Cocoa Flavanols and Cardiovascular Health | USC Journal Most recently, a 28-day study found that the consumption of cocoa flavanols reduced platelet aggregation in a group of healthy volunteers, an effect not ...