Skip to main content
Clinical Trials/NCT02147223
NCT02147223
Completed
Not Applicable

Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status

Heinrich-Heine University, Duesseldorf1 site in 1 country24 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
24
Locations
1
Primary Endpoint
Absolute change of Flow-mediated Vasodilation (FMD)
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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

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 post-menopausal femal subjects (\>50 years)
  • healthy male subjects (\>50 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

Absolute change of Flow-mediated Vasodilation (FMD)

Time Frame: 2 hours

Secondary Outcomes

  • Pulse wave velocity(2 hours)
  • Augmentation index(2 hours)
  • Ambulatory blood pressure(2 hours)
  • Plasma flavanol metabolites(2 hours)
  • laboratory safety parameters(2 hours)

Study Sites (1)

Loading locations...

Similar Trials