Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: flavanol; Dietary Supplement: flavanol + methylxanthine; Dietary Supplement: methylxanthine

• Registration Number: NCT02149238
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
flavanol rich drink intervention	flavanol	flavanol rich drink
flavanol + methylxanthine rich drink intervention	flavanol + methylxanthine	flavanol + methylxanthine rich drink
methylxanthine rich drink intervention	methylxanthine	methylxanthine rich drink

Primary Outcome Measures

Name	Time	Method
Endothelial function	2 hours	Flow mediated dilatation (FMD)
Plasma flavanol metabolites	2 hours	Measured by HPLC

Secondary Outcome Measures

Name	Time	Method
Ambulatory blood pressure	2 hours	automatical measurements
Circulation angiogenetic cells	2 hours
Pulse wave velocity	2 hours	Measured by SphygmoCor

Trial Locations

Locations (1)

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