Sex-dependent Effects of Flavanols on Vascular Status

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Flavanol free intervention; Dietary Supplement: Flavanol rich intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02147223

BRANDED

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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Flavanol rich product A

Active Comparator group

Description:

250 mg flavanols

Treatment:

Dietary Supplement: Flavanol free intervention

Dietary Supplement: Flavanol rich intervention

Flavanol rich product B

Active Comparator group

Description:

500 mg flavanols

Treatment:

Dietary Supplement: Flavanol free intervention

Dietary Supplement: Flavanol rich intervention

Flavanol rich product C

Active Comparator group

Description:

750 mg flavanols

Treatment:

Dietary Supplement: Flavanol free intervention

Dietary Supplement: Flavanol rich intervention

Flavanol free product

Placebo Comparator group

Description:

flavanol free

Treatment:

Dietary Supplement: Flavanol rich intervention