Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Health
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Endothelial function
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
PD Dr. med. Christian Heiss
Heinrich-Heine University, Duesseldorf
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)
Outcomes
Primary Outcomes
Endothelial function
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Secondary Outcomes
- Plasma lipids(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
- 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.)