Healthy Young
Conditions
Keywords
vascular function, endothelial function, polyphenols
Brief summary
Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.
Interventions
DIETARY_SUPPLEMENTcranberry (poly)phenol containing supplement
Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.
DIETARY_SUPPLEMENTPlacebo comparator: cranberry (poly)phenol deprived supplement
Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male subjects (no clinical signs or symptoms of CVD) * Young \>18 years, \<35 years
Exclusion criteria
* CVD * acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * CRP \> 1 mg/dl * malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change form Baseline Endothelial function at 1 month | 2 hours and 1 month | Measured by Flow mediated dilation (FMD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse wave velocity | Baseline and 1 month | Measured by SphygmoCor 0 and 2 hours postconsumption |
| Blood pressure | Baseline and 1month | automatical measurements 0 and 2 hours postconsumption |
| high density lipoproteins (HDL) | Baseline and 1 month | measured on baseline and after 1 month |
| low density lipoproteins (LDL) | Baseline and 1 month | measured on baseline and after 1 month |
| triglyceride | Baseline and 1 month | measured on baseline and after 1 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma cranberry (poly)phenol metabolites | Baseline and 1 month | Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption |
| Urinary cranberry (poly)phenol metabolites | Baseline and 1 month | Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption |
Countries
Germany
Outcome results
None listed