Endothelial FunctionNCT07747714
Black Forest Cocoa Flavanol Supplementation and Health Trial
A study testing Cocoa Flavanol Supplement in people with Endothelial Function and Oxidative Stress, run by The Black Forest LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function, Oxidative Stress, Inflamation
- What is being tested?
- Cocoa Flavanol Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Black Forest Supplements (The Black Forest LLC)
Miami, Florida, 33166
Shlomi Brielle, PhD, (617) 744-9534, shlomi.brielle@gmail.com
sbrielle@g.harvard.edu
Power Wellness Spot
Miami, Florida, 33166
Shlomi Brielle, PhD, (617) 744-9534, shlomi.brielle@gmail.com
shlomi.brielle@gmail.com
About this study
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.
Read the detailed 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 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
- Conditions
- Endothelial Function, Oxidative Stress, Inflamation, Vascular Health
- Being tested
- Cocoa Flavanol Supplement, Low-Flavanol Control Powder
- Keywords
- Cocoa Flavanols, Flavanol Supplementation, Endothelial Biomarkers, Vascular Function, Endothelial Progenitor Cells, Nitric Oxide, Inflammatory Biomarkers, Pulse Wave Velocity, Flow-Mediated Dilation, Nutrition Study, Dietary Supplement, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa Flavanol SupplementDietary supplement
Also called Cocoa Flavanols, CF 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 PowderDietary supplement
Also called Control Supplement, Low-Flavanol Cocoa Control
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 group | Role | What they receive |
|---|---|---|
| Cocoa Flavanol Supplement | Experimental | 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. Receives: Dietary Supplement: Cocoa Flavanol Supplement |
| Low-Flavanol Control | Placebo comparator | 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. Receives: Dietary Supplement: Low-Flavanol Control Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Stromal Cell-Derived Factor 1 Alpha Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating E-Selectin Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Intercellular Adhesion Molecule-1 Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Vascular Cell Adhesion Molecule-1 Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating C-C Motif Chemokine Ligand 4 Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating C-C Motif Chemokine Ligand 2 Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Interferon-Gamma Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Tumor Necrosis Factor-Alpha Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Interleukin-10 Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Interleukin-1 Beta Concentration
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.
Measured: Baseline and Week 4
Change From Baseline in Circulating Leptin Concentration
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.
Measured: Baseline and Week 4
Secondary outcomes (2)
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.
Measured: Baseline and 4 weeks after the first dose
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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to receive either Cocoa Flavanol supplementation or a nutrient-matched low-flavanol control product for 4-8 weeks in a double-blind parallel-group design.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Black Forest LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomi Brielle, PhD, Principal investigator, The Black Forest LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747714
- Sponsor's protocol ID
- BF-CF-HEALTH-001
- Other IDs
- Pro00092276
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate, de-identified study results are planned for publication. Individual participant-level data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Forest Cocoa Flavanol Supplementation and Health Trial
- ClinicalTrials.gov ID
- NCT07747714
- Acronym / sponsor ID
- BF-CF-HEALTH-001
- Conditions
- Endothelial Function, Oxidative Stress, Inflamation, Vascular Health
- Keywords
- Cocoa Flavanols, Flavanol Supplementation, Endothelial Biomarkers, Vascular Function, Endothelial Progenitor Cells, Nitric Oxide, Inflammatory Biomarkers, Pulse Wave Velocity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Black Forest LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to receive either Cocoa Flavanol supplementation or a nutrient-matched low-flavanol control product for 4-8 weeks in a double-blind parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| Cocoa Flavanol Supplement | Experimental | Dietary Supplement: Cocoa Flavanol SupplementParticipants 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. |
| Low-Flavanol Control | Placebo comparator | Dietary Supplement: Low-Flavanol Control PowderParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa Flavanol SupplementAlso: Cocoa Flavanols, CF 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. | Dietary supplement | Cocoa Flavanol Supplement |
| Low-Flavanol Control PowderAlso: Control Supplement, Low-Flavanol Cocoa ControlA 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. | Dietary supplement | Low-Flavanol Control |
Primary outcome
Change From Baseline in Circulating C-Reactive Protein Concentration
Time frame: 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.
Change From Baseline in Circulating Interleukin-6 Concentration
Time frame: 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.
Change From Baseline in Circulating Vascular Endothelial Growth Factor A Concentration
Time frame: 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.
Change From Baseline in Circulating Endothelin-1 Concentration
Time frame: 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.
Change From Baseline in Circulating Stromal Cell-Derived Factor 1 Alpha Concentration
Time frame: 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.
Change From Baseline in Circulating E-Selectin Concentration
Time frame: 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.
Change From Baseline in Circulating Intercellular Adhesion Molecule-1 Concentration
Time frame: 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.
Change From Baseline in Circulating Vascular Cell Adhesion Molecule-1 Concentration
Time frame: 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.
Change From Baseline in Circulating C-C Motif Chemokine Ligand 4 Concentration
Time frame: 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.
Change From Baseline in Circulating C-C Motif Chemokine Ligand 2 Concentration
Time frame: 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.
Change From Baseline in Circulating Interferon-Gamma Concentration
Time frame: 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.
Change From Baseline in Circulating Tumor Necrosis Factor-Alpha Concentration
Time frame: 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.
Change From Baseline in Circulating Interleukin-10 Concentration
Time frame: 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.
Change From Baseline in Circulating Interleukin-1 Beta Concentration
Time frame: 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.
Change From Baseline in Circulating Leptin Concentration
Time frame: 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.
2 secondary outcomes
Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
Time frame: Baseline and 4 weeks after the first dose
Change From Baseline in Circulating Nitric Oxide Metabolite Concentration
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Only aggregate, de-identified study results are planned for publication. Individual participant-level data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shlomi Brielle, PhD principal investigator
The Black Forest LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa Flavanol Supplement in people with Endothelial Function and Oxidative Stress, run by The Black Forest LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shlomi Brielle, PhD ((617) 744-9534, briellescientific@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Circulating C-Reactive Protein Concentration (time frame: Baseline and Week 4). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.