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

Vasodilation Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292342
• Other study ID #: EpicatechinStudy
• Status: Completed
• Phase: Phase 0
• First received: October 23, 2014
• Last updated: May 27, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vasodilation

Intervention

Dietary Supplement:
• Water
Control
• Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
• Epicatechin 0.5 mg/kg
EC 0.5
• Epicatechin 1.0 mg/kg
EC 1.0

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilatation		baseline to 2h	No
Secondary	Laser Doppler Imaging with Iontophoresis		baseline to 2h	No
Secondary	Plasma (-)-epicatechin metabolites		baseline to 24h	No
Secondary	Plasma nitrate/nitrite		baseline to 2h	No