Vascular Health
Conditions
Keywords
flavanols, diet, endothelial function, blood pressure, FLAVIOLA
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.
Interventions
DIETARY_SUPPLEMENTFlavanol (410 mg)
DIETARY_SUPPLEMENTControl (no flavanols)
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| Flavanol metabolites | day 0 [baseline], and day 30 each 0 and 2h |
| Microvascular function | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
| Microparticles | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
| Dietary pattern | Time points: day 0 [baseline] and day 30 |
| Vascular stiffness | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
Countries
Germany
Outcome results
None listed