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

University of Reading

Status and phase: Completed; Early Phase 1

Conditions: Vasodilation

Treatments: Dietary Supplement: Epicatechin 1.0 mg/kg; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.5 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02292342

EpicatechinStudy

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 4 patient groups, including a placebo group

0.1 mg/ kg BW pure (-)-epicatechin

Active Comparator group

Description:

0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.

Treatment:

Dietary Supplement: Epicatechin 1.0 mg/kg

Dietary Supplement: Water

Dietary Supplement: Epicatechin 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg

0.5 mg/ kg BW pure (-)-epicatechin

Active Comparator group

Description:

0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.

Treatment:

Dietary Supplement: Epicatechin 1.0 mg/kg

Dietary Supplement: Water

Dietary Supplement: Epicatechin 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg

1.0 mg/ kg BW pure (-)-epicatechin

Active Comparator group

Description:

1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.

Treatment:

Dietary Supplement: Epicatechin 1.0 mg/kg

Dietary Supplement: Water

Dietary Supplement: Epicatechin 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg

0.0 mg/ kg BW pure (-)-epicatechin

Placebo Comparator group

Description:

Water only (3 ml/kg BW)

Treatment:

Dietary Supplement: Epicatechin 1.0 mg/kg

Dietary Supplement: Water

Dietary Supplement: Epicatechin 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg