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

Early Phase 1

Completed

• Conditions: Vasodilation
• Interventions: Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Epicatechin 0.5 mg/kg; Dietary Supplement: Epicatechin 1.0 mg/kg

• Registration Number: NCT02292342
• Lead Sponsor: University of Reading

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Primary Completion: 2016-02
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1.0 mg/ kg BW pure (-)-epicatechin	Water	1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 1.0 mg/kg	Water only (3 ml/kg BW)
0.1 mg/ kg BW pure (-)-epicatechin	Water	0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.1 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.5 mg/kg	0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.5 mg/ kg BW pure (-)-epicatechin	Water	0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
1.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.1 mg/kg	1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.5 mg/kg	Water only (3 ml/kg BW)
0.1 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.1 mg/kg	0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.5 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.5 mg/kg	0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.5 mg/ kg BW pure (-)-epicatechin	Epicatechin 1.0 mg/kg	0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
1.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 1.0 mg/kg	1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.1 mg/ kg BW pure (-)-epicatechin	Epicatechin 1.0 mg/kg	0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.5 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.1 mg/kg	0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.0 mg/ kg BW pure (-)-epicatechin	Water	Water only (3 ml/kg BW)
0.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.1 mg/kg	Water only (3 ml/kg BW)
1.0 mg/ kg BW pure (-)-epicatechin	Epicatechin 0.5 mg/kg	1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.

Primary Outcome Measures

Name	Time	Method
Flow mediated dilatation	baseline to 2h

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences; 🇬🇧 Reading, Berkshire, United Kingdom