Age-dependent Effects of Flavanols on Vascular Status

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Flavanol rich intervention; Dietary Supplement: Flavanol free control

• Registration Number: NCT01639781
• 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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-13
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-14
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flavanol rich intervention	Flavanol rich intervention	flavanol rich drink
flavanol free intervention	Flavanol free control	flavanol free drink

Primary Outcome Measures

Name	Time	Method
Endothelial function	change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14	Flow mediated dilatation (FMD)

Secondary Outcome Measures

Name	Time	Method
NO bioavailability	14 days	Measured by CLD
Pulse wave velocity	14 days	Measured by SphygmoCor
Erythrocyte deformability	14 days	Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)
Ambulatory blood pressure	blood pressure at day 0 and at day 14	automatical measurements
Heart rate	14 days	Measured by ECG
Plasma flavanol metabolites	analysis of metabolites between first treatment at day 0 and after last treatment at day 14	Measured by HPLC
Microvascular function	14 days	Measured by Laserdoppler perfusion imaging (LDPI)
Augmentation index	14 days	Measured by SphygmoCor

Trial Locations

Locations (1)

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