Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Cardiovascular Diseases Clinical Trial

— New Drink  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149238
• Other study ID #: New Drink
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: December 19, 2014
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• flavanol

• methylxanthine

• flavanol + methylxanthine

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonology and Vascular Medicine	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Flow mediated dilatation (FMD)	2 hours	No
Primary	Plasma flavanol metabolites	Measured by HPLC	2 hours	No
Secondary	Pulse wave velocity	Measured by SphygmoCor	2 hours	No
Secondary	Ambulatory blood pressure	automatical measurements	2 hours	No
Secondary	Circulation angiogenetic cells		2 hours	No