search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Bioavailability of phenolics from olive leaf extract.


- candidate number10566
- NTR NumberNTR3160
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2011
- Secondary IDsNL38388-068.11 CCMO
- Public TitleBioavailability of phenolics from olive leaf extract.
- Scientific TitlePharmacokinetic study to assess the bioavailability of phenolics from an olive leaf extract.
- ACRONYMBO-PKA
- hypothesisBioactive metabolites of oleuropein are bioavailable in pre- and postmenopausal women.
- Healt Condition(s) or Problem(s) studiedPharmacokinetics, oleuropein metabolites
- Inclusion criteriaGROUP 1:
1. Premenopausal women between 18 and 75 years old;
2. No history of hormone-related disorders or surgical interventions affecting female hormone balance (e.g. ovariectomy);
3. 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;
4. Only non‐smoking individuals can participate, who did not smoke during at least 6 months before the start of the study;
5. The participants are capable and willing to sign the Informed Consent Form at voluntary basis, after having received detailed information;
6. The volunteers are considered healthy based on their medical history as questioned by the investigator;
7. The volunteers do not intend to become pregnant prior to or during the study.

GROUP 2:
1. Postmenopausal women (between 18 and 75 years old) as determined by the principal investigator. The participants should be at least 2 years post menopausal;
2. During the last ten days prior to the test day, the subjects are not allowed to use hormones, medicinal products, food supplements, anti-osteoporosis medication or vitamins that can influence bone metabolism or the test product. Subjects are allowed to continue chronic use of other drugs, which do not influence the outcome of the study;
3. Only non‐smoking individuals can participate, who did not smoke during at least 6 months before the start of the study;
4. The participants are capable and willing to sign the Informed Consent Form at voluntary basis, after having received detailed information.
- Exclusion criteria1. Clinically significant abnormal liver functioning (serum alanine and aspartate aminotransferase);
2. Clinically significant abnormal serum creatinin;
3. Abnormal BMI (i.e. lower than 18 or higher than 30);
4. Use of concomitant medications or supplements;
5. Blood donation during the last 4 weeks prior to the first dosing till 4 weeks after the last dosing.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate
- Target number of participants16
- InterventionsSingle dose administration of olive leaf extract, followed by blood and urine collection over period of 24h.
- Primary outcomeConcentrations of oleuropein metabolites in plasma and urine over 24h upon single dose administration of olive leaf extract standardized on oleuropein.
- Secondary outcome1. Differences in pharmacokinetic profiles between pre- and postmenopausal women;
2. Activity of circulating oleuropein metabolites towards bone metabolism markers in ex vivo assay.
- TimepointsSingle dose study, with 24h collection of plasma and urine.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. F. Vanmolkot
- CONTACT for SCIENTIFIC QUERIESDr. F. Vanmolkot
- Sponsor/Initiator Bio-Actor BVBA
- Funding
(Source(s) of Monetary or Material Support)
Bio-Actor BVBA
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-nov-2011 - 5-dec-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl