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Bioavailability of phenolics from olive leaf extract.

Conditions
pharmacokinetics of oleuropein metabolites
Registration Number
NL-OMON21153
Lead Sponsor
BioActor BV
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

GROUP 1:

1. Premenopausal women between 18 and 75 years old;

Exclusion Criteria

1. Clinically significant abnormal liver functioning (serum alanine and aspartate aminotransferase);

2. Clinically significant abnormal serum creatinin;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Concentrations of oleuropein metabolites in plasma and urine over 24h upon single dose administration of olive leaf extract standardized on oleuropein.
Secondary Outcome Measures
NameTimeMethod
1. Differences in pharmacokinetic profiles between pre- and postmenopausal women;<br /><br>2. Activity of circulating oleuropein metabolites towards bone metabolism markers in ex vivo assay.
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