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Flavonols and Endothelial Injury

NCT03488823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-05-15

No results posted yet for this study

Summary

With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.

Conditions

  • Endothelial Dysfunction

Interventions

DIETARY_SUPPLEMENT

with Flavanol

Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.

DIETARY_SUPPLEMENT

without Flavanol

Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Sponsors & Collaborators

  • Klinik für Kardiologie, Pneumologie und Angiologie

    lead OTHER

Principal Investigators

  • Roberto Sansone, MD · Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03488823 on ClinicalTrials.gov