Status:
COMPLETED
An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men
Lead Sponsor:
University of Reading
Conditions:
Vasodilation
Eligibility:
MALE
18-40 years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02292342
Start Date
May 1 2014
End Date
May 1 2016
Last Update
May 30 2016
Active Locations (1)
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1
Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom, RG6 6AP