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

NCT ID: NCT01479699

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

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.

Conditions

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Absorption and Metabolism Effect on Vascular Function Effect on Cytokine Concentrations

Keywords

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Olive leaf extract Polyphenols Vascular function Bioavailability Cytokines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo capsule

Four placebo capsules containing safflower oil only

Group Type PLACEBO_COMPARATOR

Olive leaf extract capsules

Intervention Type DIETARY_SUPPLEMENT

Four capsules taken at baseline each containing 4mg oleuropein

Olive leaf extract capsule

Four olive leaf capsules. Each containing 4mg oleuropein plus safflower oil.

Group Type ACTIVE_COMPARATOR

Olive leaf extract capsules

Intervention Type DIETARY_SUPPLEMENT

Four capsules taken at baseline each containing 4mg oleuropein

Interventions

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Olive leaf extract capsules

Four capsules taken at baseline each containing 4mg oleuropein

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Comvita UK

UNKNOWN

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor of Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy PE Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Ian Rowland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Parveen Yaqoob, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Hugh Sinclair Unit of Human Nutrition, University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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OLE study

Identifier Type: -

Identifier Source: org_study_id