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

NCT ID: NCT02517801

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Post-menopausal Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Anthocyanin capsules

Chronic intake of 2 capsules for 30 days (2x daily)

Group Type: EXPERIMENTAL

Anthocyanin capsules

Intervention Type: DIETARY_SUPPLEMENT

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)

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: DIETARY_SUPPLEMENT

Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.

Interventions

Anthocyanin capsules

Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.

Intervention Type: DIETARY_SUPPLEMENT

placebo capsules

Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonology and Vascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Rodriguez-Mateos, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Christian Heiss, MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Locations

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, , Germany

Countries

Germany

Other Identifiers

Anthocyanins

Identifier Type: -

Identifier Source: org_study_id