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

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.

Study Overview

• Status: Completed
• Conditions: Post-menopausal Women
• Intervention / Treatment: Dietary supplement: Anthocyanin capsules; Dietary supplement: placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anthocyanin capsules; Chronic intake of 2 capsules for 30 days (2x daily)	Dietary supplement: Anthocyanin capsules; Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.
Placebo Comparator: placebo capsules; Chronic intake of 2 capsules for 30 days (2x daily)	Dietary supplement: placebo capsules; Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption	Baseline and on day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30
Central blood pressure	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30
Heart rate	measured by SphygmoCor at 0 and 2 hours postconsumption	Baseline and on day 30
Ambulatory blood pressure	measured by Tonoport V , 24 h continuous measurement postconsumption	Baseline and on day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Ana Rodriguez-Mateos, PhD, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf; Study Chair: Christian Heiss, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: vascular function; endothelial function; anthocyanins; Post-menopausal women
• Other Study ID Numbers: Anthocyanins