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Clinical Trials/NCT02149238
NCT02149238
Completed
Not Applicable

Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Heinrich-Heine University, Duesseldorf1 site in 1 country36 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
36
Locations
1
Primary Endpoint
Endothelial function
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Heinrich-Heine University, Duesseldorf

Eligibility 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

Outcomes

Primary Outcomes

Endothelial function

Time Frame: 2 hours

Flow mediated dilatation (FMD)

Plasma flavanol metabolites

Time Frame: 2 hours

Measured by HPLC

Secondary Outcomes

  • Ambulatory blood pressure(2 hours)
  • Circulation angiogenetic cells(2 hours)
  • Pulse wave velocity(2 hours)

Study Sites (1)

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