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BOSS: "Bioequivalence of oral protein supplements after bolus intake in healthy elderly"


- candidate number23524
- NTR NumberNTR5604
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2015
- Secondary IDsPRT.1.C/A, Nutricia Research 
- Public TitleBOSS: "Bioequivalence of oral protein supplements after bolus intake in healthy elderly"
- Scientific TitleBOSS: "Bioequivalence of oral protein supplements after bolus intake in healthy elderly"
- ACRONYMBOSS
- hypothesisTo investigate whether amino acid area under the curve (AUC) and Cmax of product B is equivalent to amino acid AUC and Cmax of product A
- Healt Condition(s) or Problem(s) studiedBioequivalence
- Inclusion criteria- Healthy volunteers
- Age 60-80 years of age (both inclusive)
- BMI from 20 through 30 kg/m2
- Exclusion criteria- Any gastrointestinal (GI) disease or surgery that interferes with GI function
- Known renal or hepatic failure
- Known or suspected Diabetes Mellitus (fasting glucose level ¡Ư 7.0 mmol/L)
- Fever (>38.5 oC) in the last 7 days prior to Visit 1
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-jan-2016
- planned closingdate21-jan-2016
- Target number of participants15
- InterventionsAfter an overnight fast, subjects will ingest one dosage of one of the two study products at each study visit (except during screening).
- Primary outcomeThe primary outcome parameters in this study are amino acid AUC [́mol/L*min] and Cmax [́mol/L]
- Secondary outcome- Amino acid Tmax [min] and t½ AUC [min]
- Glutamine, Essential amino acids and sum amino acids AUC [́mol/L*min], Cmax [́mol/L], Tmax [min] and t½ AUC [min]
- Safety and GI tolerance parameters
- TimepointsTime points of the outcome: Study visit 1-2
- Trial web siteNA
- statusplanned
- 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 Foundation
- Publications
- Brief summaryBackground of the study:
In this study it will be investigated whether equimolar dosages of two proteins will produce bioequivalent amino acid serum levels in healthy older adults. Each subject will come for a screening visit and when eligible for two study visits. At each study visit the subjects will consume one dosage of one of the two study products after which a series of blood samples will be taken.
- Main changes (audit trail)
- RECORD22-dec-2015 - 14-feb-2016


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