Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations

Conditions
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Absorption and Metabolism, Effect on Vascular Function, Effect on Cytokine Concentrations

Intervention / Treatment
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* Dietary Supplement: Olive leaf extract capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsule<br>Four placebo capsules containing safflower oil only | Dietary Supplement: Olive leaf extract capsules<br>* Four capsules taken at baseline each containing 4mg oleuropein<br>|
| Active Comparator: Olive leaf extract capsule<br>Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil. | Dietary Supplement: Olive leaf extract capsules<br>* Four capsules taken at baseline each containing 4mg oleuropein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption and metabolism | Olive leaf polyphenol metabolites measured in blood and urine samples | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Vascular function was assessed via two methods: Laser Doppler Iontophoresis (LDI) and Digital Volume Pulse (DVP) | 0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP) | 
| Cytokine concentration | Concentrations of IL-8, IL-1beta, IL-6, IL-10 and TNF-alpha will be measured in whole blood stimulated with LPS. | 0, 1, 3 and 6 hours post ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive leaf extract, Polyphenols, Vascular function, Bioavailability, Cytokines