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Trial record 23 of 84 for:    catechin

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

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ClinicalTrials.gov Identifier: NCT02292342
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, 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.

Condition or disease Intervention/treatment Phase
Vasodilation Dietary Supplement: Water Dietary Supplement: Epicatechin 0.1 mg/kg Dietary Supplement: Epicatechin 0.5 mg/kg Dietary Supplement: Epicatechin 1.0 mg/kg Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : May 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Water
Control

Dietary Supplement: Epicatechin 0.1 mg/kg
EC 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg
EC 0.5

Dietary Supplement: Epicatechin 1.0 mg/kg
EC 1.0

Active Comparator: 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.
Dietary Supplement: Water
Control

Dietary Supplement: Epicatechin 0.1 mg/kg
EC 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg
EC 0.5

Dietary Supplement: Epicatechin 1.0 mg/kg
EC 1.0

Active Comparator: 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.
Dietary Supplement: Water
Control

Dietary Supplement: Epicatechin 0.1 mg/kg
EC 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg
EC 0.5

Dietary Supplement: Epicatechin 1.0 mg/kg
EC 1.0

Placebo Comparator: 0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Dietary Supplement: Water
Control

Dietary Supplement: Epicatechin 0.1 mg/kg
EC 0.1 mg/kg

Dietary Supplement: Epicatechin 0.5 mg/kg
EC 0.5

Dietary Supplement: Epicatechin 1.0 mg/kg
EC 1.0




Primary Outcome Measures :
  1. Flow mediated dilatation [ Time Frame: baseline to 2h ]

Secondary Outcome Measures :
  1. Laser Doppler Imaging with Iontophoresis [ Time Frame: baseline to 2h ]
  2. Plasma (-)-epicatechin metabolites [ Time Frame: baseline to 24h ]
  3. Plasma nitrate/nitrite [ Time Frame: baseline to 2h ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292342


Locations
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United Kingdom
Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Jeremy Spencer, PhD University of Reading

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Responsible Party: Jeremy Paul Edward Spencer, Professor Jeremy P.E. Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT02292342     History of Changes
Other Study ID Numbers: EpicatechinStudy
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeremy Paul Edward Spencer, University of Reading:
Flow mediated dilatation