Absorption and Metabolism Clinical Trial
Official title:
Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
| Verified date | November 2011 |
| Source | University of Reading |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Hugh Sinclair Unit of Human Nutrition, University of Reading | Reading | Berkshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Reading | Comvita UK |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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 | No |