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

Sponsor

University of Reading (Other)

Overall Status

Completed

CT.gov ID

NCT02292342

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vasodilation	Dietary Supplement: Water Dietary Supplement: Epicatechin 0.1 mg/kg Dietary Supplement: Epicatechin 0.5 mg/kg Dietary Supplement: Epicatechin 1.0 mg/kg	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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.

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Flow mediated dilatation [baseline to 2h]

Secondary Outcome Measures

Laser Doppler Imaging with Iontophoresis [baseline to 2h]
Plasma (-)-epicatechin metabolites [baseline to 24h]
Plasma nitrate/nitrite [baseline to 2h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food and Nutritional Sciences	Reading	Berkshire	United Kingdom	RG6 6AP

Sponsors and Collaborators

University of Reading

Investigators

Principal Investigator: Jeremy Spencer, PhD, University of Reading

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeremy Paul Edward Spencer, Professor Jeremy P.E. Spencer, University of Reading

ClinicalTrials.gov Identifier:

NCT02292342

Other Study ID Numbers:

EpicatechinStudy

First Posted:

Nov 17, 2014

Last Update Posted:

May 30, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Jeremy Paul Edward Spencer, Professor Jeremy P.E. Spencer, University of Reading

Flow mediated dilatation

Study Results

No Results Posted as of May 30, 2016