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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cocoa Flavanol Supplement
Dietary supplementA 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 supplementA 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Cocoa Flavanol SupplementExperimental treatment 1 intervention
Group B: Low-Flavanol ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Circulating C-Reactive Protein Concentration
Circulating C-reactive protein will be measured in serum using a custom multiplex bead-based immunoassay. The outcome will be calculated for each participant as the Week 4 concentration minus the baseline concentration. Change from baseline will be compared between the cocoa flavanol supplementation group and the nutrient-matched low-flavanol control group.
Time frame
Baseline and Week 42
Change From Baseline in Circulating Interleukin-6 Concentration
Circulating interleukin-6 will be measured in serum or plasma using a custom multiplex bead-based immunoassay. The outcome will be calculated as the Week 4 concentration minus the baseline concentration and compared between treatment groups.
Time frame
Baseline and Week 43
Change From Baseline in Circulating Vascular Endothelial Growth Factor A Concentration
Circulating vascular endothelial growth factor A will be measured in serum or plasma using a custom multiplex bead-based immunoassay. The outcome will be calculated as the Week 4 concentration minus the baseline concentration and compared between treatment groups.
Time frame
Baseline and Week 44
Change From Baseline in Circulating Endothelin-1 Concentration
Circulating endothelin-1 will be measured in serum or plasma using a custom multiplex bead-based immunoassay. The outcome will be calculated as the Week 4 concentration minus the baseline concentration and compared between treatment groups.
Time frame
Baseline and Week 4Secondary outcomes
1
Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
Circulating endothelial progenitor cells will be quantified in peripheral blood by flow cytometry. The outcome will be calculated as the end-of-intervention value minus the baseline value and compared between the cocoa flavanol supplementation group and the nutrient-matched low-flavanol control group.
Time frame
Baseline and 4 weeks after the first dose2
Change From Baseline in Circulating Nitric Oxide Metabolite Concentration
Circulating nitric oxide metabolites will be measured in serum or plasma using the RayBiotech MA-NO metabolism assay. The outcome will be calculated for each participant as the Week 4 value minus the baseline value. Change from baseline will be compared between the cocoa flavanol supplementation group and the nutrient-matched low-flavanol control group.
Time frame
Baseline and Week 4Other outcomes
1
Change From Baseline in Peripheral Blood Mononuclear Cell-Type Abundance by Single-Cell RNA Sequencing
As an exploratory pilot analysis, single-cell RNA sequencing will be performed on peripheral blood mononuclear cells collected at baseline and Week 4 from a subset of participants. For each identified immune-cell population, cell-type abundance will be calculated as the proportion of quality-controlled cells assigned to that cell type. Exploratory changes from baseline will be evaluated within participants and compared between the cocoa flavanol supplementation and nutrient-matched low-flavanol control groups. This pilot analysis is not powered for confirmatory hypothesis testing.
Time frame
Baseline and Week 42
Exploratory Change From Baseline in Single-Cell Gene-Expression Pathway Scores
As an exploratory pilot analysis, single-cell RNA sequencing of peripheral blood mononuclear cells will be used to evaluate cell-type-specific transcriptional changes associated with inflammation, angiogenesis, oxidative stress, vascular repair, and progenitor-cell activity. Prespecified gene-expression pathway scores will be calculated within relevant cell populations. Exploratory changes from baseline to Week 4 will be evaluated within participants and compared between treatment groups. This pilot analysis is not powered for confirmatory hypothesis testing.
Time frame
Baseline and Week 4Sponsors and contacts
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Source ClinicalTrials.gov
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