Black Forest Cocoa Flavanol Supplementation and Health Trial
The Black Forest LLC
Summary
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.
Description
This is an early-phase, randomized, double-blind, controlled mechanistic clinical trial designed to evaluate the effects of daily cocoa flavanol supplementation on vascular biology and inflammatory biomarkers in healthy adults. Participants aged 30 to 75 years will be randomized in a 1:1 ratio to receive either: A cocoa flavanol supplement providing approximately 1,200 mg total flavanols daily, or A nutrient-matched low-flavanol cocoa-based control product. The intervention period will last 4 to 8 weeks. Study products will be provided in identical packaging to maintain blinding. Primary o…
Eligibility
- Age range
- 30–75 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 st…
Interventions
- Dietary SupplementCocoa Flavanol Supplement
A powdered cocoa flavanol dietary supplement administered orally once daily for 4 to 8 weeks. Each daily serving contains approximately 1,200 mg total cocoa flavanols in a 10 g powder formulation. The supplement is mixed with water or a non-alcoholic beverage and consumed in a blinded fashion.
- Dietary SupplementLow-Flavanol Control Powder
A nutrient-matched low-flavanol cocoa-based powder administered orally once daily for 4 to 8 weeks. The control product contains less than 2% total flavanols and is designed to match the active supplement in appearance, taste, and administration while minimizing biologically active flavanol exposure.
Locations (2)
- Black Forest Supplements (The Black Forest LLC)Miami, Florida
- Power Wellness SpotMiami, Florida