Clinical trial NCT01799005: FLAVIOLA Health Study
Official title: Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Health
Keywords: flavanols
diet
endothelial function
blood pressure
FLAVIOLA
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* male, age 35-60 years, healthy
* female, age 35-60 years, healthy

Exclusion Criteria:

* diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)

Primary outcomes:
measure: Endothelial function
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Secondary outcomes:
measure: Blood pressure
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
measure: Glucose
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
measure: Plasma lipids
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Other outcomes:
measure: Flavanol metabolites
timeFrame: day 0 [baseline], and day 30 each 0 and 2h
measure: Microparticles
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
measure: Dietary pattern
timeFrame: Time points: day 0 [baseline] and day 30
measure: Vascular stiffness
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
measure: Microvascular function
timeFrame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
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: Sansone R, Rodriguez-Mateos A, Heuel J, Falk D, Schuler D, Wagstaff R, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M, Heiss C; Flaviola Consortium, European Union 7th Framework Program. Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015 Oct 28;114(8):1246-55. doi: 10.1017/S0007114515002822. Epub 2015 Sep 9.