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

This study has been completed.
Sponsor:
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
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Jeremy Paul Edward Spencer, 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) ]
    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) ]
    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 ]
    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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Jeremy Paul Edward Spencer, University of Reading:
Olive leaf extract
Polyphenols
Vascular function
Bioavailability
Cytokines

ClinicalTrials.gov processed this record on August 23, 2017