Black Forest Cocoa Flavanol Supplementation and Health Trial
2026年7月31日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shlomi Brielle, PhD
- 电话号码：(617) 744-9534
- 邮箱：briellescientific@gmail.com
学习地点
-
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Florida
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Miami、Florida、美国、33166
- Black Forest Supplements (The Black Forest LLC)
-
接触：
- Shlomi Brielle, PhD
- 电话号码：(617) 744-9534
- 邮箱：shlomi.brielle@gmail.com
-
接触：
-
首席研究员：
- Shlomi Brielle, PhD
-
Miami、Florida、美国、33166
- Power Wellness Spot
-
接触：
- Shlomi Brielle, PhD
- 电话号码：(617) 744-9534
- 邮箱：shlomi.brielle@gmail.com
-
首席研究员：
- Shlomi Brielle, PhD
-
接触：
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
其他名称：
|
|
安慰剂比较：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.
|
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Circulating C-Reactive Protein Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Interleukin-6 Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Vascular Endothelial Growth Factor A Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Endothelin-1 Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Stromal Cell-Derived Factor 1 Alpha Concentration
大体时间：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.
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Baseline and Week 4
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Change From Baseline in Circulating E-Selectin Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Intercellular Adhesion Molecule-1 Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
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Change From Baseline in Circulating Vascular Cell Adhesion Molecule-1 Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
|
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Change From Baseline in Circulating C-C Motif Chemokine Ligand 4 Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
|
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Change From Baseline in Circulating C-C Motif Chemokine Ligand 2 Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Interferon-Gamma Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Tumor Necrosis Factor-Alpha Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
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Change From Baseline in Circulating Interleukin-10 Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Interleukin-1 Beta Concentration
大体时间：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.
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Baseline and Week 4
|
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Change From Baseline in Circulating Leptin Concentration
大体时间：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.
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Baseline and Week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
大体时间：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.
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Baseline and 4 weeks after the first dose
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Change From Baseline in Circulating Nitric Oxide Metabolite Concentration
大体时间：Baseline and Week 4
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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.
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Baseline and Week 4
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Peripheral Blood Mononuclear Cell-Type Abundance by Single-Cell RNA Sequencing
大体时间：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.
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Baseline and Week 4
|
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Exploratory Change From Baseline in Single-Cell Gene-Expression Pathway Scores
大体时间：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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shlomi Brielle, PhD、The Black Forest LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月15日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年1月1日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年7月31日
首次发布 (实际的)
2026年8月5日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年7月31日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- BF-CF-HEALTH-001
- Pro00092276 (其他标识符：Advarra IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Only aggregate, de-identified study results are planned for publication.
Individual participant-level data will not be shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.