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Clinical Trials/NCT01639781
NCT01639781
Completed
Phase 1

Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.

Heinrich-Heine University, Duesseldorf1 site in 1 country44 target enrollmentNovember 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
44
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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
August 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
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 participants between 18-35 years
  • healthy male participants between 50-80 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: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14

Flow mediated dilatation (FMD)

Secondary Outcomes

  • Ambulatory blood pressure(blood pressure at day 0 and at day 14)
  • Pulse wave velocity(14 days)
  • Heart rate(14 days)
  • Plasma flavanol metabolites(analysis of metabolites between first treatment at day 0 and after last treatment at day 14)
  • Erythrocyte deformability(14 days)
  • NO bioavailability(14 days)
  • Microvascular function(14 days)
  • Augmentation index(14 days)

Study Sites (1)

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