Status:
COMPLETED
Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
Lead Sponsor:
University of Reading
Collaborating Sponsors:
Comvita UK
Conditions:
Absorption and Metabolism
Effect on Vascular Function
Eligibility:
All Genders
19-40 years
Phase:
NA
Brief Summary
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system.
Detailed Description
The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on vascular function and cytokine concentrations.
Eligibility Criteria
Inclusion
- 19-40 years, non-smokers, able to swallow capsules, have a Body Mass Index (BMI) of 18.5-30, have a normal liver function and haematology and a max alcohol intake of \<21 units/week
Exclusion
- Those who suffer from any form of disease, including endocrine disease, liver disease, diabetes mellitus, myocardial infarction, blood clotting disorder, reproductive disorder, gastrointestinal disease or a chronic gastrointestinal disorder.
- Individuals who are vegetarian, have dietary restrictions or on a weight reducing diet will not be recruited.
- Subjects who have been taking antibiotics in previous 3 months before study will not be included in the study
- Females who may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions will be excluded.
- Blood pressure \> 150/90 mmHg
- Haemoglobin \< 125 g/l for male, \< 110 g/l for female
- Gamma GT (liver enzymes) \> 80 IU/l
- Cholesterol \> 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- On any lipid-modifying medication
- On any medication affecting blood clotting
- Individuals taking vitamin and/or fish oil supplements
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01479699
Start Date
June 1 2011
End Date
October 1 2011
Last Update
November 24 2011
Active Locations (1)
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1
Hugh Sinclair Unit of Human Nutrition, University of Reading
Reading, Berkshire, United Kingdom, RG6 5SG