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Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects (New Drink)

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ClinicalTrials.gov Identifier: NCT02149238
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description
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Brief Summary:

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure.

However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: flavanol Dietary Supplement: methylxanthine Dietary Supplement: flavanol + methylxanthine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
Study Start Date : February 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: flavanol rich drink intervention
flavanol rich drink
 Dietary Supplement: flavanol
Active Comparator: methylxanthine rich drink intervention
methylxanthine rich drink
 Dietary Supplement: methylxanthine
Active Comparator: flavanol + methylxanthine rich drink intervention
flavanol + methylxanthine rich drink
 Dietary Supplement: flavanol + methylxanthine


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial function [ Time Frame: 2 hours ]
    Flow mediated dilatation (FMD)

  2. Plasma flavanol metabolites [ Time Frame: 2 hours ]
    Measured by HPLC


Secondary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 2 hours ]
    Measured by SphygmoCor

  2. Ambulatory blood pressure [ Time Frame: 2 hours ]
    automatical measurements

  3. Circulation angiogenetic cells [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male subjects
  • >18 years

Exclusion Criteria:

  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP > 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): NCT02149238


Locations
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Germany
Division of Cardiology, Pulmonology and Vascular Medicine
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
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonology and Vascular Medicine
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, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02149238    
Other Study ID Numbers: New Drink
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
flavanols
cardiovascular effects
nutrition-nutrition interaction
Additional relevant MeSH terms:
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Cardiovascular Diseases