Clinical trial NCT02517801: Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women
Official title: Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-menopausal Women
Keywords: anthocyanins
Post-menopausal women
endothelial function
vascular function
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Endothelial function
timeFrame: Baseline and on day 30
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: Baseline and on day 30
measure: Central blood pressure
timeFrame: Baseline and on day 30
measure: Heart rate
timeFrame: Baseline and on day 30
measure: Ambulatory blood pressure
timeFrame: Baseline and on day 30
Other outcomes:
measure: Plasma (poly)phenol metabolites
timeFrame: Baseline and on day 30
measure: Urinary (poly)phenol metabolites
timeFrame: Baseline and on day 30
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
name: Christian Heiss, MD
role: STUDY_CHAIR
References: