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

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.

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.

Study Overview

• Status: Completed
• Conditions: Vasodilation
• Intervention / Treatment: Dietary supplement: Water; Dietary supplement: Epicatechin 0.1 mg/kg; Dietary supplement: Epicatechin 0.5 mg/kg; Dietary supplement: Epicatechin 1.0 mg/kg

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.1 mg/ kg BW pure (-)-epicatechin; 0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.	Dietary supplement: Water; Control; Dietary supplement: Epicatechin 0.1 mg/kg; EC 0.1 mg/kg; Dietary supplement: Epicatechin 0.5 mg/kg; EC 0.5; Dietary supplement: Epicatechin 1.0 mg/kg; EC 1.0
Active Comparator: 0.5 mg/ kg BW pure (-)-epicatechin; 0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.	Dietary supplement: Water; Control; Dietary supplement: Epicatechin 0.1 mg/kg; EC 0.1 mg/kg; Dietary supplement: Epicatechin 0.5 mg/kg; EC 0.5; Dietary supplement: Epicatechin 1.0 mg/kg; EC 1.0
Active Comparator: 1.0 mg/ kg BW pure (-)-epicatechin; 1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.	Dietary supplement: Water; Control; Dietary supplement: Epicatechin 0.1 mg/kg; EC 0.1 mg/kg; Dietary supplement: Epicatechin 0.5 mg/kg; EC 0.5; Dietary supplement: Epicatechin 1.0 mg/kg; EC 1.0
Placebo Comparator: 0.0 mg/ kg BW pure (-)-epicatechin; Water only (3 ml/kg BW)	Dietary supplement: Water; Control; Dietary supplement: Epicatechin 0.1 mg/kg; EC 0.1 mg/kg; Dietary supplement: Epicatechin 0.5 mg/kg; EC 0.5; Dietary supplement: Epicatechin 1.0 mg/kg; EC 1.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Flow mediated dilatation	baseline to 2h

Secondary Outcome Measures

Outcome Measure	Time Frame
Laser Doppler Imaging with Iontophoresis	baseline to 2h
Plasma (-)-epicatechin metabolites	baseline to 24h
Plasma nitrate/nitrite	baseline to 2h

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Jeremy Spencer, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Flow mediated dilatation
• Other Study ID Numbers: EpicatechinStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO