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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: October 2011
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.
- Dietary Supplement: Olive leaf extract capsules
- Four capsules taken at baseline each containing 4mg oleuropein
Arms, Groups and Cohorts
- Placebo Comparator: Placebo capsule
- Four placebo capsules containing safflower oil only
- Active Comparator: Olive leaf extract capsule
- Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil.
Clinical Trial Outcome Measures
- Absorption and metabolism
- Time Frame: 0. 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post ingestion (blood) 0, 0-4, 4-8 and 8-24 hours post ingestion (urine)
- Olive leaf polyphenol metabolites measured in blood and urine samples
- Vascular function
- Time Frame: 0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP)
- Vascular function was assessed via two methods: Laser Doppler Iontophoresis (LDI) and Digital Volume Pulse (DVP)
- Cytokine concentration
- Time Frame: 0, 1, 3 and 6 hours post ingestion
- Concentrations of IL-8, IL-1beta, IL-6, IL-10 and TNF-alpha will be measured in whole blood stimulated with LPS.
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of Reading
- Comvita UK
- Provider of Information About this Clinical Study
- Principal Investigator: Jeremy Paul Edward Spencer, Professor of Biochemistry – University of Reading
- Overall Official(s)
- Jeremy PE Spencer, PhD, Principal Investigator, University of Reading
- Ian Rowland, PhD, Principal Investigator, University of Reading
- Parveen Yaqoob, PhD, Principal Investigator, University of Reading
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