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

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.

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02292342

Enrollment

Registered

2014-11-17

Start date

2014-05-31

Completion date

2016-05-31

Last updated

2016-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasodilation

Keywords

Flow mediated dilatation

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.

Interventions

DIETARY_SUPPLEMENTWater

Control

DIETARY_SUPPLEMENTEpicatechin 0.1 mg/kg

EC 0.1 mg/kg

DIETARY_SUPPLEMENTEpicatechin 0.5 mg/kg

EC 0.5

DIETARY_SUPPLEMENTEpicatechin 1.0 mg/kg

EC 1.0

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Flow mediated dilatation	baseline to 2h

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026