NCT02517801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

July 8, 2015

Last Update Submit

November 2, 2015

Conditions

Post-menopausal Women

Keywords

anthocyaninsPost-menopausal womenendothelial functionvascular function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption

    Baseline and on day 30

Secondary Outcomes (4)

  • Pulse wave velocity

    Baseline and on day 30

  • Central blood pressure

    Baseline and on day 30

  • Heart rate

    Baseline and on day 30

  • Ambulatory blood pressure

    Baseline and on day 30

Other Outcomes (2)

  • Plasma (poly)phenol metabolites

    Baseline and on day 30

  • Urinary (poly)phenol metabolites

    Baseline and on day 30

Study Arms (2)

Anthocyanin capsules

EXPERIMENTAL

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

Dietary Supplement: Anthocyanin capsules

placebo capsules

PLACEBO COMPARATOR

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

Dietary Supplement: placebo capsules

Interventions

Anthocyanin capsulesDIETARY_SUPPLEMENT

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

Anthocyanin capsules
placebo capsulesDIETARY_SUPPLEMENT

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

placebo capsules

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Düsseldorf, 40225, Germany

Location

MeSH Terms

Interventions

Anthocyanins

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Study Officials

  • Ana Rodriguez-Mateos, PhD

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

    PRINCIPAL INVESTIGATOR

  • Christian Heiss, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Cardiology, Pulmonology and Vascular Medicine

Study Record Dates

First Submitted

July 8, 2015

First Posted

August 7, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

DE(1)