Black Forest Cocoa Flavanol Supplementation and Health Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change From Baseline in Circulating C-Reactive Protein Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, care providers, and outcome assessors are blinded to treatment allocation. Study products are packaged in identical coded containers to maintain masking.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cocoa Flavanol Supplement (Dietary Supplement)
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.
干预措施: Low-Flavanol Control Powder (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Circulating C-Reactive Protein Concentration
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in Circulating Endothelial Progenitor Cell Frequency(Baseline and 4 weeks after the first dose)
- Change From Baseline in Circulating Nitric Oxide Metabolite Concentration(Baseline and Week 4)