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Completed

NCT Number: NCT02517801

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anthocyanin capsules

Dietary Supplement

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

Placebo capsules

Dietary Supplement

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

Primary outcomes

  1. Endothelial function

    Time frame: Baseline and on day 30

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

Secondary outcomes

  1. Pulse wave velocity

    Time frame: Baseline and on day 30

    measured by SphygmoCor at 0 and 2 hours postconsumption

  2. Central blood pressure

    Time frame: Baseline and on day 30

    measured by SphygmoCor at 0 and 2 hours postconsumption

  3. Heart rate

    Time frame: Baseline and on day 30

    measured by SphygmoCor at 0 and 2 hours postconsumption

  4. Ambulatory blood pressure

    Time frame: Baseline and on day 30

    measured by Tonoport V , 24 h continuous measurement postconsumption

Other outcomes

  1. Plasma (poly)phenol metabolites

    Time frame: Baseline and on day 30

    measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0 and 2 hours postconsumption

  2. Urinary (poly)phenol metabolites

    Time frame: Baseline and on day 30

    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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: Anthocyanins

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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