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Black Forest Cocoa Flavanol Supplementation and Health Trial

31 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otros nombres:
  • Cocoa Flavanols
  • CF Supplement
Comparador de placebos: 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.
Otros nombres:
  • Control Supplement
  • Low-Flavanol Cocoa Control

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Circulating C-Reactive Protein Concentration
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Peripheral Blood Mononuclear Cell-Type Abundance by Single-Cell RNA Sequencing
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The Black Forest LLC

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

31 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2026

Publicado por primera vez (Actual)

5 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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