An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men
NCT ID: NCT02292342
Last Updated: 2016-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
21 participants
INTERVENTIONAL
2014-05-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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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.
Water
Control
Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
Epicatechin 0.5 mg/kg
EC 0.5
Epicatechin 1.0 mg/kg
EC 1.0
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.
Water
Control
Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
Epicatechin 0.5 mg/kg
EC 0.5
Epicatechin 1.0 mg/kg
EC 1.0
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.
Water
Control
Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
Epicatechin 0.5 mg/kg
EC 0.5
Epicatechin 1.0 mg/kg
EC 1.0
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
Water
Control
Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
Epicatechin 0.5 mg/kg
EC 0.5
Epicatechin 1.0 mg/kg
EC 1.0
Interventions
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Water
Control
Epicatechin 0.1 mg/kg
EC 0.1 mg/kg
Epicatechin 0.5 mg/kg
EC 0.5
Epicatechin 1.0 mg/kg
EC 1.0
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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University of Reading
OTHER
Responsible Party
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Jeremy Paul Edward Spencer
Professor Jeremy P.E. Spencer
Principal Investigators
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Jeremy Spencer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom
Countries
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Other Identifiers
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EpicatechinStudy
Identifier Type: -
Identifier Source: org_study_id