Sex-dependent Effects of Flavanols on Vascular Status

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT02147223
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-26
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Absolute change of Flow-mediated Vasodilation (FMD)	2 hours

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	2 hours	Measured by SphygmoCor
Augmentation index	2 hours	Measured by SphygmoCor
Ambulatory blood pressure	2 hours	automatical measurements
Plasma flavanol metabolites	2 hours	Measured by HPLC
laboratory safety parameters	2 hours	blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis)

Trial Locations

Locations (1)

Division of Cardiology, Pulmonology and Vascular Medicine; 🇩🇪 Duesseldorf, Germany