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OpenTrials
Completed

NCT Number: NCT02292342

An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men

Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.

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Key information

Conditions

Vasodilation Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index 20-27.5 kg/m2
  • Normal blood pressure at screening (< 150/90)
  • Non-smoker
  • Non-vegetarian
  • 'Normal - low' chocolate consumer (<2 potions per week)
  • 'Normal - low' coffee/ tea drinker (<3 cups per day)
  • Regular exercise routine
  • Signed consent form

Exclusion criteria

  • Haemoglobin (anaemia marker) < 125 g/l
  • Gamma GT (liver enzymes) > 80 IU/l
  • Cholesterol > 6.5 mmol/l
  • Suffered a myocardial infarction or stroke in the last 12 months
  • Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
  • Suffers from any blood-clotting disorder, and/or takes supporting medication
  • Any dietary restrictions or on a weight reducing diet
  • On any lipid-modifying or blood pressure lowering medication
  • Consuming any specific vitamin/ herbal supplements or fish oils

Treatment and study plan

Water

Dietary Supplement

Control

Epicatechin 0.1 mg/kg

Dietary Supplement

EC 0.1 mg/kg

Epicatechin 0.5 mg/kg

Dietary Supplement

EC 0.5

Epicatechin 1.0 mg/kg

Dietary Supplement

EC 1.0

Primary outcomes

  1. Flow mediated dilatation

    Time frame: baseline to 2h

Secondary outcomes

  1. Laser Doppler Imaging with Iontophoresis

    Time frame: baseline to 2h

  2. Plasma (-)-epicatechin metabolites

    Time frame: baseline to 24h

  3. Plasma nitrate/nitrite

    Time frame: baseline to 2h

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

An Acute, Double-blind, Randomised, Placebo-controlled, Crossover Intervention Trial Investigating the Dose-dependent Vascular Effects of Pure (-)-Epicatechin (≤1 mg/kg BW) in Healthy Men.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2014
Registry last updated
May 30, 2016

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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