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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Vasodilation

Intervention / Treatment
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* Dietary Supplement: Water
* Dietary Supplement: Epicatechin 0.1 mg/kg
* Dietary Supplement: Epicatechin 0.5 mg/kg
* Dietary Supplement: Epicatechin 1.0 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation |  | baseline to 2h | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flow mediated dilatation