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Beschikbaarheid van uridine in het bloed van gezonde ouderen na eenmalige inname van een nucleotide en een alternatief ingrediënt.


- candidate number22407
- NTR NumberNTR5289
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2015
- Secondary IDsAlz.1.P/E Nutricia Research
- Public TitleBeschikbaarheid van uridine in het bloed van gezonde ouderen na eenmalige inname van een nucleotide en een alternatief ingrediënt.
- Scientific TitleBioequivalence of uridine bioavailability in healthy elderly after bolus intake of a nucleotide and an alternative ingredient.
- ACRONYMBUMP
- hypothesisTo investigate whether uridine (Urd) area under the curve (AUC) and Cmax of product B is equivalent to the Urd AUC and Cmax of product A
- Healt Condition(s) or Problem(s) studiedBioequivalence
- Inclusion criteria1. Healthy volunteers
2. Age 60 years or older
3. BMI from 20 through 30 kg/m2
- Exclusion criteria1. Any condition that may interfere with the definition ‘healthy volunteer’ according to the investigator, with special attention to the presence of liver and renal disease, diabetes mellitus, Alzheimer, diarrhea, obstipation and known severe weight loss (> 3 kg in last 3 months)
2. Any gastrointestinal (GI) disease or surgery that interferes with GI function
3. (History of) any cancer with the exception of basal cell carcinoma
4. Any sign of inflammation in the last 7 days prior to Visit 1
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jul-2015
- planned closingdate10-sep-2015
- Target number of participants25
- InterventionsAfter an overnight fast, subjects will ingest one dosage of one of the five study products at each study visit (except during screening).
- Primary outcomeThe primary outcome parameters in this study are Urd AUC [́mol/L*min] and Cmax [́mol/L] (product B versus A).
- Secondary outcomeThe secondary outcome parameters in this study are Urd AUC [́mol/L*min] and Cmax [́mol/L], Tmax [min] and t½ AUC [min] , Urd AUC [́mol/L*min], Cmax [́mol/L], Tmax [min] and t½ AUC [min].
- TimepointsTime points of the outcome: Study visit 1-5
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. van Helvoort
- CONTACT for SCIENTIFIC QUERIES A Veenendaal
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsNA
- Brief summaryBackground of the study:
In this study it will be investigated whether equimolar dosages of a nucleotide and an alternative ingredient will produce bioequivalent Urd plasma levels.
In this study healthy older adults are requested to consume 5 different study products. Each subject will visit the site 5 times and at every visit they will consume 1 of the 5 products after which a series of blood samples will be taken.
- Main changes (audit trail)
- RECORD6-jul-2015 - 19-aug-2015


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