Black Forest Cocoa Flavanol Supplementation and Health Trial

Conditions

• Endothelial Function
• Inflamation
• Oxidative Stress
• Vascular Health

Eligibility Criteria

Sex

MALE

Age

30 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Cocoa Flavanol Supplement — DIETARY_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.
• Low-Flavanol Control Powder — DIETARY_SUPPLEMENT
  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.

Study Details

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 Dates

First listed

Aug 5, 2026

Start date

Aug 15, 2026

Status verified

Jul 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Cocoa Flavanol Supplement
  Participants will receive a daily cocoa flavanol powder supplement providing approximately 1,200 mg total cocoa flavanols per day for 4 to 8 weeks. The supplement will be administered orally once daily in a blinded fashion.
• Placebo Comparator: Low-Flavanol Control
  Participants will receive a nutrient-matched low-flavanol cocoa-based powder containing less than 2% total flavanols for 4 to 8 weeks. The control product is designed to match the active supplement in appearance and administration while minimizing biologically active flavanol exposure.

Primary Outcome Measure

Change From Baseline in Circulating C-Reactive Protein Concentration [ Time Frame: Baseline and Week 4 ]

Central Contacts

• Shlomi Brielle, PhD
  ‪(617) 744-9534‬
  [email protected]

Locations (2)

Find similar trials in Miami, FL

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