Clinical trial NCT01479699: Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
Official title: Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption and Metabolism
Effect on Vascular Function
Effect on Cytokine Concentrations
Keywords: Olive leaf extract
Polyphenols
Vascular function
Bioavailability
Cytokines
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Comvita UK
First posted: 2011-11-24
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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 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

Primary outcomes:
measure: Absorption and metabolism
timeFrame: 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)
Secondary outcomes:
measure: Vascular function
timeFrame: 0, 2, 4, 6 hours post ingestion (LDI) 0, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours post ingestion (DVP)
measure: Cytokine concentration
timeFrame: 0, 1, 3 and 6 hours post ingestion
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy PE Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Ian Rowland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Parveen Yaqoob, PhD
role: PRINCIPAL_INVESTIGATOR
References: