Clinical trial NCT01639781: Age-dependent Effects of Flavanols on Vascular Status
Official title: Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: flavanols
age related cardiovascular effects
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: University of Reading
First posted: 2012-07-13
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endothelial function
timeFrame: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14
Secondary outcomes:
measure: Plasma flavanol metabolites
timeFrame: analysis of metabolites between first treatment at day 0 and after last treatment at day 14
measure: Ambulatory blood pressure
timeFrame: blood pressure at day 0 and at day 14
measure: Pulse wave velocity
timeFrame: 14 days
measure: Microvascular function
timeFrame: 14 days
measure: Augmentation index
timeFrame: 14 days
measure: Heart rate
timeFrame: 14 days
measure: Erythrocyte deformability
timeFrame: 14 days
measure: NO bioavailability
timeFrame: 14 days
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
citation: Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27.