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Completed

NCT Number: NCT01479699

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

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.

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Key information

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hugh Sinclair Unit of Human Nutrition, University of Reading

Reading, Berkshire, RG6 5SG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olive leaf extract capsules

Dietary Supplement

Four capsules taken at baseline each containing 4mg oleuropein

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Comvita UK

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.