To 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
ID
Bron
Verkorte titel
Aandoening
Bioequivalence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameters in this study are amino acid AUC [ìmol/L*min] and Cmax [ìmol/L]
Achtergrond van het onderzoek
Background 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.
Doel van het onderzoek
To 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
Onderzoeksopzet
Time points of the outcome: Study visit 1-2
Onderzoeksproduct en/of interventie
After an overnight fast, subjects will ingest one dosage of one of the two study products at each study visit (except during screening).
Publiek
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
Wetenschappelijk
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Healthy volunteers
- Age 60-80 years of age (both inclusive)
- BMI from 20 through 30 kg/m2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Any gastrointestinal (GI) disease or
surgery that interferes with GI function
- Known renal or hepatic failure
- Known or suspected Diabetes Mellitus
(fasting glucose level ¡Ý 7.0 mmol/L)
- Fever (>38.5 oC) in the last 7 days prior
to Visit 1
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5460 |
| NTR-old | NTR5604 |
| Ander register | : PRT.1.C/A, Nutricia Research |