Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2014-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
Flavanols and procyanidins deprived supplement
Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
control supplement deprived of flavanols and procyanidins
Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
Interventions
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Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
control supplement deprived of flavanols and procyanidins
Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
Eligibility Criteria
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Inclusion Criteria
* \>18 years, \<35 years
Exclusion Criteria
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C-reactive protein \> 1 mg/dl
* malignant disease
18 Years
35 Years
MALE
Yes
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Klinik für Kardiologie, Pneumologie und Angiologie
Division of Cardiology, Pulmonary Diseases, Vascular Medicine
Principal Investigators
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Christian Heiß, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Malte Kelm, Prof. MD
Role: STUDY_CHAIR
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Locations
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Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, , Germany
Countries
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References
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Rodriguez-Mateos A, Weber T, Skene SS, Ottaviani JI, Crozier A, Kelm M, Schroeter H, Heiss C. Assessing the respective contributions of dietary flavanol monomers and procyanidins in mediating cardiovascular effects in humans: randomized, controlled, double-masked intervention trial. Am J Clin Nutr. 2018 Dec 1;108(6):1229-1237. doi: 10.1093/ajcn/nqy229.
Other Identifiers
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12-018
Identifier Type: OTHER
Identifier Source: secondary_id
Cocoa procyanidins
Identifier Type: -
Identifier Source: org_study_id
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