Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women

Post-menopausal Women Clinical Trial

— Anthocyanins  

Official title:

Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517801
• Other study ID #: Anthocyanins
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: November 2, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post-menopausal Women

Intervention

Dietary Supplement:
• Anthocyanin capsules
Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.
• placebo capsules
Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma (poly)phenol metabolites	measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0 and 2 hours postconsumption	Baseline and on day 30	No
Other	Urinary (poly)phenol metabolites	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	Baseline and on day 30	No
Primary	Endothelial function	Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption	Baseline and on day 30	No
Secondary	Pulse wave velocity	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30	No
Secondary	Central blood pressure	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30	No
Secondary	Heart rate	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30	No
Secondary	Ambulatory blood pressure	measured by Tonoport V , 24 h continuous measurement postconsumption	Baseline and on day 30	No