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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Flow mediated dilatation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Epicatechin 0.5 mg/kg (Dietary Supplement)
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.
Intervention: Water (Dietary Supplement)
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.
Intervention: Epicatechin 0.1 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 0.1 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 0.5 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 1.0 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 1.0 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 0.1 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 0.5 mg/kg (Dietary Supplement)
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.
Intervention: Epicatechin 1.0 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Intervention: Epicatechin 0.1 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Intervention: Epicatechin 0.5 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Intervention: Epicatechin 1.0 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Intervention: Water (Dietary Supplement)
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.
Intervention: Water (Dietary Supplement)
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.
Intervention: Water (Dietary Supplement)
Outcomes
Primary Outcomes
Flow mediated dilatation
Time Frame: baseline to 2h
Secondary Outcomes
- Plasma (-)-epicatechin metabolites(baseline to 24h)
- Laser Doppler Imaging with Iontophoresis(baseline to 2h)
- Plasma nitrate/nitrite(baseline to 2h)
Investigators
Jeremy Paul Edward Spencer
Professor Jeremy P.E. Spencer
University of Reading