Healthy Men
Conditions
Keywords
polyphenols, vascular function, endothelial function, cranberry, healthy
Brief summary
Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.
Interventions
DIETARY_SUPPLEMENTCranberry 320
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
DIETARY_SUPPLEMENTCranberry 640
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
DIETARY_SUPPLEMENTCranberry 960
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
DIETARY_SUPPLEMENTCranberry 1280
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
DIETARY_SUPPLEMENTCranberry 1600
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
DIETARY_SUPPLEMENTCranberry deprived supplement
Cranberry deprived supplement Acute intake of 500 mL (1x daily)
Sponsors
The Cranberry Institute
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male subjects without clinical signs or symptoms of cardiovascular disease
Exclusion criteria
* cardiovascular disease * acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * C-reactive protein \> 05 mg/dL * malignant disease * cranberry allergy/intolerance * hypotension (≤100 / 60 mm Hg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pulse wave velocity | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake |
| Central blood pressure | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake |
| Peripheral blood pressure | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake |
| Heart Rate | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma (poly)phenol metabolites | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0,1, 2, 4, 6, 8 and 24 hours after intake |
| Urinary (poly)phenol metabolites | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0, 8 and 24 hours after intake |
Countries
Germany
Outcome results
None listed