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Black Forest Cocoa Flavanol Supplementation and Health Trial

31 de julho de 2026 atualizado por: The Black Forest LLC
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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 objectives include evaluating changes in biomarkers associated with endothelial function and systemic inflammation, including hs-CRP, IL-6, IL-1β, IL-10, VCAM-1, ICAM-1, E-selectin, TNF-α, CCL2, CCL4, and IFN-γ.

Secondary objectives include assessment of oxidative stress and vascular tone markers, blood pressure, pulse wave velocity, endothelial progenitor cell-related markers, endothelial microparticles, and nitric oxide-related biomarkers. Optional mechanistic assessments include flow-mediated dilation and single-cell RNA sequencing analyses in a participant subset.

Blood samples and vascular measurements will be obtained at baseline and at the end of the intervention period. The study is designed to explore physiologic and biomarker responses associated with cocoa flavanol supplementation in a healthy adult population

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Florida
      • Miami, Florida, Estados Unidos, 33166
        • Black Forest Supplements (The Black Forest LLC)
        • Contato:
        • Contato:
        • Investigador principal:
          • Shlomi Brielle, PhD
      • Miami, Florida, Estados Unidos, 33166

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Suplemento dietético: Cocoa 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.
Outros nomes:
  • Cocoa Flavanols
  • CF Supplement
Comparador de Placebo: 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.
Suplemento dietético: Low-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.
Outros nomes:
  • Control Supplement
  • Low-Flavanol Cocoa Control

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Circulating C-Reactive Protein Concentration
Prazo: Baseline and Week 4
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.
Baseline and Week 4
Change From Baseline in Circulating Interleukin-6 Concentration
Prazo: Baseline and Week 4
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.
Baseline and Week 4
Change From Baseline in Circulating Vascular Endothelial Growth Factor A Concentration
Prazo: Baseline and Week 4
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.
Baseline and Week 4
Change From Baseline in Circulating Endothelin-1 Concentration
Prazo: Baseline and Week 4
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.
Baseline and Week 4
Change From Baseline in Circulating Stromal Cell-Derived Factor 1 Alpha Concentration
Prazo: Baseline and Week 4
Circulating stromal cell-derived factor 1 alpha, also known as SDF-1α or CXCL12, 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.
Baseline and Week 4
Change From Baseline in Circulating E-Selectin Concentration
Prazo: Baseline and Week 4
Circulating E-selectin 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.
Baseline and Week 4
Change From Baseline in Circulating Intercellular Adhesion Molecule-1 Concentration
Prazo: Baseline and Week 4
Circulating intercellular adhesion molecule-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.
Baseline and Week 4
Change From Baseline in Circulating Vascular Cell Adhesion Molecule-1 Concentration
Prazo: Baseline and Week 4
Circulating vascular cell adhesion molecule-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.
Baseline and Week 4
Change From Baseline in Circulating C-C Motif Chemokine Ligand 4 Concentration
Prazo: Baseline and Week 4
Circulating C-C motif chemokine ligand 4, also known as CCL4, 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.
Baseline and Week 4
Change From Baseline in Circulating C-C Motif Chemokine Ligand 2 Concentration
Prazo: Baseline and Week 4
Circulating C-C motif chemokine ligand 2, also known as CCL2, 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.
Baseline and Week 4
Change From Baseline in Circulating Interferon-Gamma Concentration
Prazo: Baseline and Week 4
Circulating interferon-gamma 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.
Baseline and Week 4
Change From Baseline in Circulating Tumor Necrosis Factor-Alpha Concentration
Prazo: Baseline and Week 4
Circulating tumor necrosis factor-alpha 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.
Baseline and Week 4
Change From Baseline in Circulating Interleukin-10 Concentration
Prazo: Baseline and Week 4
Circulating interleukin-10 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.
Baseline and Week 4
Change From Baseline in Circulating Interleukin-1 Beta Concentration
Prazo: Baseline and Week 4
Circulating interleukin-1 beta 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.
Baseline and Week 4
Change From Baseline in Circulating Leptin Concentration
Prazo: Baseline and Week 4
Circulating leptin 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.
Baseline and Week 4

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
Prazo: Baseline and 4 weeks after the first dose
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.
Baseline and 4 weeks after the first dose
Change From Baseline in Circulating Nitric Oxide Metabolite Concentration
Prazo: Baseline and Week 4
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.
Baseline and Week 4

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Peripheral Blood Mononuclear Cell-Type Abundance by Single-Cell RNA Sequencing
Prazo: Baseline and Week 4
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.
Baseline and Week 4
Exploratory Change From Baseline in Single-Cell Gene-Expression Pathway Scores
Prazo: Baseline and Week 4
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.
Baseline and Week 4

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Black Forest LLC

Investigadores

  • Investigador principal: Shlomi Brielle, PhD, The Black Forest LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de agosto de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

31 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de julho de 2026

Primeira postagem (Real)

5 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • BF-CF-HEALTH-001
  • Pro00092276 (Outro identificador: Advarra IRB)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Only aggregate, de-identified study results are planned for publication. Individual participant-level data will not be shared.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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