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

University of Reading

Status: Completed

Conditions: Effect on Cytokine Concentrations; Effect on Vascular Function; Absorption and Metabolism

Treatments: Dietary Supplement: Olive leaf extract capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT01479699

OLE study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Placebo capsule

Placebo Comparator group

Description:

Four placebo capsules containing safflower oil only

Treatment:

Dietary Supplement: Olive leaf extract capsules

Olive leaf extract capsule

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Olive leaf extract capsules