Black Forest Cocoa Flavanol Supplementation and Health Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-75
SponsorThe Black Forest LLC
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cocoa Flavanol Supplement
- Low-Flavanol Control Powder
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov