Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects (New Drink)

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: flavanol + methylxanthine; Dietary Supplement: flavanol; Dietary Supplement: methylxanthine

Study type: Interventional

Funder types: Other

Identifiers

NCT02149238

New Drink

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 3 patient groups

flavanol rich drink intervention

Active Comparator group

Description:

flavanol rich drink

Treatment:

Dietary Supplement: flavanol

methylxanthine rich drink intervention

Active Comparator group

Description:

methylxanthine rich drink

Treatment:

Dietary Supplement: methylxanthine

flavanol + methylxanthine rich drink intervention

Active Comparator group

Description:

flavanol + methylxanthine rich drink

Treatment:

Dietary Supplement: flavanol + methylxanthine