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Low Flavanol Cocoa Powder for Cardiovascular Disease

Q: Is the study recruiting adults of 18 years or older?

<p>This medical trial has a set age range of 30 to 50 as an inclusion criteria. 28 separate studies are dedicated to those younger than 18 and 394 trials focus on individuals aged 65 or higher.</p>

Q: How many participants can this trial accommodate?

<p>Affirmative. The clinicaltrials.gov listing indicates that enrollment is ongoing for this medical research endeavor, which was established on September 1st 2022 and last edited a few weeks later. Five patients are desired from one location in particular.</p>

N/A

Recruiting

Led By Carl L Keen

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours

Awards & highlights

Study Summary

This trial will study the potential health benefits of a product containing chardonnay marc, which is the solid residue left over from wine-making. The trial will collect data on how the product affects cardiometabolic health and the gut microbiome, and will assess the response of selected outcomes after 6 hours of flavanol intake.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't specified but could include typical food-related reactions such as allergies or gastrointestinal discomfort due to the ingredients in the tested products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Framingham Reactive Hyperemia Index (fRHI)

Secondary outcome measures

Glucose

Insulin

Platelet aggregation

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Vine to Bar Chocolate covered AlmondsExperimental Treatment2 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 ChocolateExperimental Treatment2 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 ChocolateExperimental Treatment4 Interventions

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

Group IV: High Flavanol Cocoa PowderExperimental Treatment4 Interventions

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

Group V: Low Flavanol Cocoa PowderPlacebo Group3 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

914 Previous Clinical Trials

4,720,823 Total Patients Enrolled

Carl L KeenPrincipal InvestigatorDistinguished Professor Emeritus of Nutrition

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study recruiting adults of 18 years or older?

"This medical trial has a set age range of 30 to 50 as an inclusion criteria. 28 separate studies are dedicated to those younger than 18 and 394 trials focus on individuals aged 65 or higher."

Answered by AI

How many participants can this trial accommodate?

"Affirmative. The clinicaltrials.gov listing indicates that enrollment is ongoing for this medical research endeavor, which was established on September 1st 2022 and last edited a few weeks later. Five patients are desired from one location in particular."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chardonnay Marc and Vascular Response

Carl L. Keen, PhD 2022. "Chardonnay Marc and Vascular Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05545865.