FLAVIOLA Health Study

Not Applicable

Completed

• Conditions: Vascular Health
• Interventions: Dietary Supplement: Flavanol (410 mg); Dietary Supplement: Control (no flavanols)

• Registration Number: NCT01799005
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-24
• Study First Submitted QC: 2013-02-24
• Study First Posted: 2013-02-26
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-01
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flavanol rich intervention	Flavanol (410 mg)	Ingestion of 410mg flavanols twice a day for 30 days
flavanol free intervention	Control (no flavanols)	Ingestion of a macro and micro nutrients matched flavanol free drink

Primary Outcome Measures

Name	Time	Method
Endothelial function	Time points: day 0 [baseline], and day 30 each 0 and 2h.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Time points: day 0 [baseline], and day 30 each 0 and 2h.
Glucose	Time points: day 0 [baseline], and day 30 each 0 and 2h.
Plasma lipids	Time points: day 0 [baseline], and day 30 each 0 and 2h.

Trial Locations

Locations (1)

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