Absorption and Metabolism, Effect on Cytokine Concentrations, Effect on Vascular Function
Conditions
Keywords
Olive leaf extract, Polyphenols, Vascular function, Bioavailability, Cytokines
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.
Interventions
DIETARY_SUPPLEMENTOlive leaf extract capsules
Four capsules taken at baseline each containing 4mg oleuropein
Sponsors
Comvita UK
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absorption and metabolism | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular function | 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 | 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. |
Countries
United Kingdom
Outcome results
None listed