Black Forest Cocoa Flavanol Supplementation and Health Trial

Starting soon · Not applicable

Conditions studied: Endothelial Function, Oxidative Stress, Inflamation, Vascular Health

In brief

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.

Key facts

Study ID

NCT07747714

Run by

The Black Forest LLC

People needed

90

Starts

2026-08-15

Expected to finish

2027-01-01

Last updated by the study team

2026-08-05

Who can join

Age: 30 and older, up to 75. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male participants aged 30 to 75 years.
• Able and willing to provide written informed consent.
• Generally healthy, as determined by medical history and screening assessments.
• 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 provide peripheral blood samples at baseline and at the end of the intervention.
• Willing to maintain generally stable dietary, exercise, sleep, medication, and supplement habits during the study.
• Willing to refrain from initiating new supplements, restrictive diets, fasting regimens, or major exercise programs during the study.
• Not currently taking medications or supplements known to substantially affect vascular function, nitric oxide pathways, inflammation, oxidative stress, or coagulation, unless approved by the investigator.

You may not qualify if…

• Female biological sex.
• Younger than 30 years or older than 75 years.
• Known cardiovascular, metabolic, renal, hepatic, inflammatory, or autoimmune disease, including coronary artery disease, diabetes mellitus, chronic kidney disease, chronic liver disease, rheumatoid arthritis, or another clinically significant inflammatory disorder.
• Hypertension requiring prescription medication.
• Active infection, acute illness, or other clinically significant medical condition at screening or baseline.
• Current use of medications or supplements that may substantially affect vascular function, inflammatory biomarkers, nitric oxide pathways, oxidative stress, or coagulation, including chronic nonsteroidal anti-inflammatory drugs, systemic corticosteroids, anticoagulants, antiplatelet drugs, prescription immunomodulatory agents, phosphodiesterase-5 inhibitors, or high-dose antioxidant supplements, unless approved by the investigator.
• Known allergy, hypersensitivity, or intolerance to cocoa, chocolate, cocoa flavanols, or any ingredient in either study product.
• Gastrointestinal disease or condition that may interfere with digestion or absorption of the study product, including celiac disease, inflammatory bowel disease, active gastritis, or a clinically significant malabsorption disorder.
• Current smoking or vaping of nicotine or cannabis products.
• Major psychiatric illness, cognitive impairment, or another condition that may interfere with informed consent, adherence, or completion of study procedures.
• Alcohol or drug abuse within the previous 12 months that, in the investigator's judgment, may affect participant safety or study adherence.
• Participation in another interventional clinical study within 30 days before screening.
• Plans to begin a new medication, supplement, restrictive diet, fasting regimen, or major exercise program during the study period.
• Any condition or circumstance that, in the investigator's judgment, would increase participant risk, interfere with study procedures, compromise adherence, or affect interpretation of the study results.

Where it is running

• Black Forest Supplements (The Black Forest LLC) — Miami, Florida, United States
• Power Wellness Spot — Miami, Florida, United States

Full record on ClinicalTrials.gov

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