Post-menopausal Women
Conditions
Keywords
anthocyanins, Post-menopausal women, endothelial function, vascular function
Brief summary
Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. The investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male volunteers. There were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. A large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. Whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.
Interventions
DIETARY_SUPPLEMENTAnthocyanin capsules
Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.
DIETARY_SUPPLEMENTplacebo capsules
Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis * \> 50 years
Exclusion criteria
* cardiovascular disease * acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * C-reactive protein \> 0.5 mg/dL * malignant disease * hypotension (≤100 / 60 mm Hg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Baseline and on day 30 | Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse wave velocity | Baseline and on day 30 | measured by SphygmoCor at 0 and 2 hours postconsumption |
| Central blood pressure | Baseline and on day 30 | measured by SphygmoCor at 0 and 2 hours postconsumption |
| Heart rate | Baseline and on day 30 | measured by SphygmoCor at 0 and 2 hours postconsumption |
| Ambulatory blood pressure | Baseline and on day 30 | measured by Tonoport V , 24 h continuous measurement postconsumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma (poly)phenol metabolites | Baseline and on day 30 | measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0 and 2 hours postconsumption |
| Urinary (poly)phenol metabolites | Baseline and on day 30 | measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0-12 and 12-24 hours post consumption |
Countries
Germany
Outcome results
None listed