Age-dependent Effects of Flavanols on Vascular Status

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01639781

AGE-111-CH

FLA-111-CH (Other Identifier)

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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Enrollment: 44 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male participants between 18-35 years
• healthy male participants between 50-80 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: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

flavanol rich intervention

Active Comparator group

Description:

flavanol rich drink

Treatment:

Dietary Supplement: Flavanol rich intervention

flavanol free intervention

Placebo Comparator group

Description:

flavanol free drink

Treatment:

Dietary Supplement: Flavanol free control