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Completed

NCT Number: NCT03118791

Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Düsseldorf, 40225, Germany

About this study

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. A double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. On 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be performed. The aim is to investigate whether purified anthocyanins are able to increase FMD at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men aged 18-45 years old
  • Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study
  • able to give signed written informed consent
  • signed written infomred consent form
  • healthy male subjects (no clinical signs or symptoms of CVD.

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

anthocyanins

Dietary Supplement

Acute intake of capsules

Primary outcomes

  1. Endothelial function

    Time frame: Changes from baseline to 2 hours postconsumption

    Flow-mediated dilation

Secondary outcomes

  1. Blood pressure

    Time frame: 0 and 2 hours postconsumption

    Automatic measurements

Other outcomes

  1. Other Pre-specified Outcome Measures

    Time frame: 0 and 2 hours postconsumption

    Plasma (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS)

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2017
Registry last updated
Nov 9, 2017

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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