Black Forest Cocoa Flavanol Supplementation and Health Trial
2026년 7월 31일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
중재적
등록 (추정된)
등록
90
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Shlomi Brielle, PhD
- 전화번호: (617) 744-9534
- 이메일: briellescientific@gmail.com
연구 장소
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Florida
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Miami, Florida, 미국, 33166
- Black Forest Supplements (The Black Forest LLC)
-
연락하다:
- Shlomi Brielle, PhD
- 전화번호: (617) 744-9534
- 이메일: shlomi.brielle@gmail.com
-
연락하다:
-
수석 연구원:
- Shlomi Brielle, PhD
-
Miami, Florida, 미국, 33166
- Power Wellness Spot
-
연락하다:
- Shlomi Brielle, PhD
- 전화번호: (617) 744-9534
- 이메일: shlomi.brielle@gmail.com
-
수석 연구원:
- Shlomi Brielle, PhD
-
연락하다:
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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위약 비교기: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Circulating C-Reactive Protein Concentration
기간: 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
기간: Baseline and Week 4
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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
기간: Baseline and Week 4
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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
기간: 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
기간: Baseline and Week 4
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline and Week 4
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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
기간: Baseline and Week 4
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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
기간: 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
기간: 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
기간: Baseline and Week 4
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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
기간: Baseline and Week 4
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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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Circulating Endothelial Progenitor Cell Frequency
기간: Baseline and 4 weeks after the first dose
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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
기간: 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.
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Baseline and Week 4
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Peripheral Blood Mononuclear Cell-Type Abundance by Single-Cell RNA Sequencing
기간: Baseline and Week 4
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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
기간: Baseline and Week 4
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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.
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Baseline and Week 4
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Shlomi Brielle, PhD, The Black Forest LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 15일
기본 완료 (추정된)
기본 완료
2027년 1월 1일
연구 완료 (추정된)
연구 완료
2027년 1월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 31일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 31일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 5일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 31일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- BF-CF-HEALTH-001
- Pro00092276 (기타 식별자: Advarra IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Only aggregate, de-identified study results are planned for publication.
Individual participant-level data will not be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .