NCT02292342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

October 23, 2014

Last Update Submit

May 27, 2016

Conditions

Vasodilation

Keywords

Flow mediated dilatation

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilatation

    baseline to 2h

Secondary Outcomes (3)

  • Laser Doppler Imaging with Iontophoresis

    baseline to 2h

  • Plasma (-)-epicatechin metabolites

    baseline to 24h

  • Plasma nitrate/nitrite

    baseline to 2h

Study Arms (4)

0.1 mg/ kg BW pure (-)-epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: WaterDietary Supplement: Epicatechin 0.1 mg/kgDietary Supplement: Epicatechin 0.5 mg/kgDietary Supplement: Epicatechin 1.0 mg/kg

0.5 mg/ kg BW pure (-)-epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: WaterDietary Supplement: Epicatechin 0.1 mg/kgDietary Supplement: Epicatechin 0.5 mg/kgDietary Supplement: Epicatechin 1.0 mg/kg

1.0 mg/ kg BW pure (-)-epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: WaterDietary Supplement: Epicatechin 0.1 mg/kgDietary Supplement: Epicatechin 0.5 mg/kgDietary Supplement: Epicatechin 1.0 mg/kg

0.0 mg/ kg BW pure (-)-epicatechin

PLACEBO COMPARATOR

Water only (3 ml/kg BW)

Dietary Supplement: WaterDietary Supplement: Epicatechin 0.1 mg/kgDietary Supplement: Epicatechin 0.5 mg/kgDietary Supplement: Epicatechin 1.0 mg/kg

Interventions

WaterDIETARY_SUPPLEMENT

Control

0.0 mg/ kg BW pure (-)-epicatechin0.1 mg/ kg BW pure (-)-epicatechin0.5 mg/ kg BW pure (-)-epicatechin1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 0.1 mg/kgDIETARY_SUPPLEMENT

EC 0.1 mg/kg

0.0 mg/ kg BW pure (-)-epicatechin0.1 mg/ kg BW pure (-)-epicatechin0.5 mg/ kg BW pure (-)-epicatechin1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 0.5 mg/kgDIETARY_SUPPLEMENT

EC 0.5

0.0 mg/ kg BW pure (-)-epicatechin0.1 mg/ kg BW pure (-)-epicatechin0.5 mg/ kg BW pure (-)-epicatechin1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 1.0 mg/kgDIETARY_SUPPLEMENT

EC 1.0

0.0 mg/ kg BW pure (-)-epicatechin0.1 mg/ kg BW pure (-)-epicatechin0.5 mg/ kg BW pure (-)-epicatechin1.0 mg/ kg BW pure (-)-epicatechin

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Aneurysm

Interventions

WaterCatechin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsChromansBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFlavonoidsChromonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jeremy Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jeremy P.E. Spencer

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 17, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

May 30, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)