Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
This study has been completed.
Sponsor:
University of Reading
Collaborator:
Comvita UK
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading
ClinicalTrials.gov Identifier:
NCT01479699
First received: November 22, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Absorption and Metabolism Effect on Vascular Function Effect on Cytokine Concentrations |
Dietary Supplement: Olive leaf extract capsules |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations |
Further study details as provided by University of Reading:
Primary 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) ] [ Designated as safety issue: No ]Olive leaf polyphenol metabolites measured in blood and urine samples
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Concentrations of IL-8, IL-1beta, IL-6, IL-10 and TNF-alpha will be measured in whole blood stimulated with LPS.
| Enrollment: | 18 |
| Study Start Date: | June 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo capsule
Four placebo capsules containing safflower oil only
|
Dietary Supplement: Olive leaf extract capsules
Four capsules taken at baseline each containing 4mg oleuropein
|
|
Active Comparator: Olive leaf extract capsule
Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil.
|
Dietary Supplement: Olive leaf extract capsules
Four capsules taken at baseline each containing 4mg oleuropein
|
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| Ages Eligible for Study: | 19 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479699
Locations
| United Kingdom | |
| Hugh Sinclair Unit of Human Nutrition, University of Reading | |
| Reading, Berkshire, United Kingdom, RG6 5SG | |
Sponsors and Collaborators
University of Reading
Comvita UK
Investigators
| Principal Investigator: | Jeremy PE Spencer, PhD | University of Reading |
| Principal Investigator: | Ian Rowland, PhD | University of Reading |
| Principal Investigator: | Parveen Yaqoob, PhD | University of Reading |
More Information
No publications provided
| Responsible Party: | Jeremy Paul Edward Spencer, Professor of Biochemistry, University of Reading |
| ClinicalTrials.gov Identifier: | NCT01479699 History of Changes |
| Other Study ID Numbers: | OLE study |
| Study First Received: | November 22, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Reading:
|
Olive leaf extract Polyphenols Vascular function Bioavailability Cytokines |
ClinicalTrials.gov processed this record on May 22, 2013