Cocoa Flavanol Supplement for Vascular Health

Not yet recruiting at 1 trial location
SB
Overseen ByShlomi Brielle, PhD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: The Black Forest LLC

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized, double-blind, controlled clinical trial will evaluate the effects of daily cocoa flavanol supplementation on vascular and inflammatory biomarkers in healthy adult men aged 30 to 75 years. Participants will be randomized to receive either a cocoa flavanol supplement or a nutrient-matched low-flavanol control product for 4 to 8 weeks. The study will assess changes in inflammatory biomarkers, endothelial function, oxidative stress markers, vascular measurements, and circulating endothelial progenitor cell-related markers. Optional assessments include flow-mediated dilation and single-cell RNA sequencing of peripheral blood mononuclear cells to explore mechanistic biological responses to cocoa flavanol supplementation.

Who Is on the Research Team?

SB

Shlomi Brielle, PhD

Principal Investigator

The Black Forest LLC

Are You a Good Fit for This Trial?

This trial is for healthy men aged 30 to 75 years. Participants should not have major health problems and must be able to take a daily supplement for up to 8 weeks.

Inclusion Criteria

Willing and able to comply with all study procedures including blood collection, daily study-product intake, and required study visits
Willing to consume the assigned cocoa flavanol supplement or low-flavanol control product once daily for the duration of the study
Willing to refrain from initiating new supplements, restrictive diets, fasting regimens, or major exercise programs during the study
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Exclusion Criteria

I do not have any major psychiatric or cognitive conditions that affect my decision-making.
I was born biologically female.
Current smoking or vaping of nicotine or cannabis products
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What Are the Treatments Tested in This Trial?

Interventions

  • Cocoa Flavanol Supplement

Trial Overview

The study tests whether taking a daily cocoa flavanol supplement improves blood vessel health and reduces inflammation compared to a similar powder with low flavanols. Participants are randomly assigned to one of the two groups, and neither they nor the researchers know which group they're in.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cocoa Flavanol SupplementExperimental Treatment1 Intervention
Group II: Low-Flavanol ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Black Forest LLC

Lead Sponsor