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Curcumin study: Plasma concentrations of curcumin, piperin and genistein in subjects using over the counter supplements.


- candidate number25396
- NTR NumberNTR6111
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2016
- Secondary IDsNL58755.018.16 Curcumin study
- Public TitleCurcumin study: Plasma concentrations of curcumin, piperin and genistein in subjects using over the counter supplements.
- Scientific TitleCurcumin study: Plasma concentrations of curcumin, piperin and genistein in subjects using over the counter supplements.
- ACRONYMCurcumine onderzoek
- hypothesisDespite pre-clinical evidence the effectiveness of curcumin in clinical trails is limited. Currently foodsupplements are available as over the counter products with probably fallacious claims about the bioavailability. Prices of 40-50 euros per bottel of curcumin with or without piperin or genistein are common. Despite this patients currently use this supplement in additional care. In this pilot research we want to investigate which products, formulations and dosages patients use and measure the plasma levels reached during intake of these supplements.
- Healt Condition(s) or Problem(s) studiedCurcumin, Cancer, Drug
- Inclusion criteriaadults, currently using curcumin foodsupplement as a over the counter product, patient in AMC, able to give informed consent
- Exclusion criteriaInability to give informed consent
inability to follow instructions of the investigator
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 17-okt-2016
- planned closingdate17-okt-2017
- Target number of participants50
- Interventionsnone
- Primary outcomeThe aim of this study is to investigate if curcumin is detectable when patients use curcumin supplements in daily life.
- Secondary outcomeBesides curcumin we want to investigate which herbal products or drugs are used by patients, which may be influence the bioavailability of curcumin, such as piperine and perhaps genistein.
- Timepoints17-okt-2016 start of study
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES J.K. Berbee
- CONTACT for SCIENTIFIC QUERIES J.K. Berbee
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryThe aim of the study is to investigate if curcumin is detectable when subjects use curcumin supplements in daily life. During a single visit to the hospital a questionnaire about the food supplement use by subjects and two blood samples will be collected. One sample before intake and one sample after intake of the food supplement. With a validated method the concentrations of curcumin, piperin and genistein and their metabolites will be measured.
- Main changes (audit trail)29-ap-2017:
14-dec-2016: METC approval for amendment:
-Inclusion criteria added: Healthy participants/visitors of the AMC
- Recruitment method added: Recruitment via treating physician via a folder. Travel cost will be reimbursed if visit cannot be combined with a regular visit. Personal bloodvalues can be given at the end of the study.
- RECORD12-okt-2016 - 12-okt-2017


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