NCT01799005

FLAVIOLA Health Study

Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.

Conditions

• Vascular Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flavanol (410 mg)
DIETARY_SUPPLEMENT	Control (no flavanols)

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-02-26
• Last updated: 2015-02-03

Locations

1 site across 1 country: Germany