No registrations found.
ID
Source
Brief title
Health condition
Bioequivalence
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters in this study are amino acid AUC [ìmol/L*min] and Cmax [ìmol/L]
Secondary outcome
- Amino acid Tmax [min] and t½ AUC [min]
- Glutamine, Essential amino acids and sum
amino acids AUC [ìmol/L*min], Cmax
[ìmol/L], Tmax [min] and t½ AUC [min]
- Safety and GI tolerance parameters
Background summary
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.
Study objective
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
Study design
Time points of the outcome: Study visit 1-2
Intervention
After an overnight fast, subjects will ingest one dosage of one of the two study products at each study visit (except during screening).
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
A. van Helvoort
PO Box 80141
Utrecht 3508 TC
The Netherlands
Tel. +31-30-2095000
Email: A.vanHelvoort@nutricia.com
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 ¡Ý 7.0 mmol/L)
- Fever (>38.5 oC) in the last 7 days prior
to Visit 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5460 |
| NTR-old | NTR5604 |
| Other | : PRT.1.C/A, Nutricia Research |