Pharmacokinetic study to assess the bioavailability of phenolics from an olive leaf extract

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 31

Inclusion Criteria

-Female adults between 18 and 75 years old
-The study will consist of 8 premenopausal and 8 postmenopausal women.
-Only non*smoking individuals can participate. Non*smoking individuals are hereby defined as individuals who did not smoke during at least 6 months before the start of the study. Individuals who did not smoke for minimum 3 months prior to the study could also be included, upon evaluation and decision by the investigators.
-The participants are capable and willing to sign the Informed Consent Form at voluntary basis, after having received detailed information.
-The volunteers are considered healthy based on their medical history as questioned by the investigator during an interview and a general physical examination by the investigator.
-Female volunteers do not intend to become pregnant prior to or during the study and using adequate contraception.
-Premenopausal women should be on monophasic oral anti conception and the test day should not be in the pause week or in the first 3 days of pill use, in order to obtain a constant level of estrogen.
-The postmenopausal women should be at least 2 years post menopausal to ensure a homogeneous population

Exclusion Criteria

-Clinically significant abnormal liver functioning (serum alanine and aspartate aminotransferase).
-Clinically significant abnormal serum creatinin.
-Abnormal BMI (i.e. lower than 18 or higher than 30).
-Use of concomitant medications or supplements.
-Blood donation during the last 4 weeks prior to the first dosing till 4 weeks after the last dosing.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of the study is to evaluate the bioavailability and<br /><br>pharmacokinetics of the phenolics present in the olive leaf extract and the<br /><br>metabolites which are formed upon administration of a dose which was previously<br /><br>shown to have biological activity. Assessment and evaluation will be done by<br /><br>analyzing the plasma and urinary concentrations of the main study parameter:<br /><br>the olive phenolics oleuropein, hydroxytyrosol, tyrosol and their human<br /><br>metabolites in the plasma and urine following a single oral consumption of the<br /><br>olive leaf extract. To do this, blood samples will be collected pre-dose and<br /><br>after 30 min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 16h and 24h. Urine will be collected<br /><br>and pooled as follows: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h.</p><br>

Secondary Outcome Measures