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Effects of Cocoa Procyanidins on Vascular Function

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ClinicalTrials.gov Identifier: NCT02728466
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description
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Brief Summary:
There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites & metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Flavanol and procyanidin supplement Dietary Supplement: Procyanidin-containing supplement Dietary Supplement: control supplement deprived of flavanols and procyanidins Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
 Dietary Supplement: Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Active Comparator: Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
 Dietary Supplement: Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
Placebo Comparator: 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
 Dietary 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


Outcome Measures
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Primary Outcome Measures :
  1. Change form Baseline Endothelial function at 1 month [ Time Frame: Baseline and 1 month ]
    Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month


Secondary Outcome Measures :
  1. Plasma flavanol metabolites [ Time Frame: Baseline and 1 month ]
    Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption

  2. Urinary flavanol metabolites [ Time Frame: Baseline and 1 month ]
    Measured up to 24 hours post consumption on day 1 and 1 month after consumption

  3. Urinary valerolactone metabolites [ Time Frame: Baseline and 1 month ]
    Measured up to 24 hours post consumption on day 1 and 1 month after consumption


Other Outcome Measures:
  1. Pulse wave velocity [ Time Frame: Baseline and 1 month ]
    Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month.

  2. Blood pressure [ Time Frame: Baseline and 1 month ]
    automatical measurements on baseline 2 hours postconsumption and on 1 month

  3. high density lipoproteins (HDL) [ Time Frame: Baseline and 1 month ]
    measured on baseline and after 1 month

  4. low density lipoproteins (LDL) [ Time Frame: Baseline and 1 month ]
    measured on baseline and after 1 month

  5. cholesterol [ Time Frame: Baseline and 1 month ]
    measured on baseline and after 1 month

  6. triglyceride [ Time Frame: Baseline and 1 month ]
    measured on baseline and after 1 month


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
  • >18 years, <35 years

Exclusion Criteria:

  • cardiovascular disease
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • C-reactive protein > 1 mg/dl
  • malignant disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728466


Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Christian Heiß, MD Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Study Chair: Malte Kelm, Prof. MD Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02728466    
Other Study ID Numbers: Cocoa procyanidins
12-018 ( Other Identifier: CTSU )
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
flavanols
cocoa procyanidins
vascular function
endothelial function
Additional relevant MeSH terms:
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Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents