The objective of the study is to investigate the bioequivalence of 2 different proteins with regards to bioavailabillity in healthy elderly after one oral bolus intake.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dit is een bioequivalentie onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameters in this study are Amino Acid AUC [µmol/L*min]
and Cmax [µmol/L]
Secondary outcome
The secondary outcome parameters in this study are:
- Amino Acid Tmax [min] and t* AUC [min]
- Glutamine, EAA and sum AA AUC [µmol/L*min], Cmax [µmol/L], Tmax [min] and t*
AUC [min]
- Safety and GI tolerance parameters
Background summary
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
The objective of the study is to investigate the bioequivalence of 2 different
proteins with regards to bioavailabillity in healthy elderly after one oral
bolus intake.
Study design
Randomised; double-blind; crossover; single-centre; single-dose
Intervention
After an overnight fast, subjects will ingest one dosage of one of the two
study products at each study visit (except during screening).
Study burden and risks
There are no known undesirable effects after the intake of the study products.
Expected risks associated with the protocol are minimal. No noticeable effects
are expected, except for known side effects of blood collection by a canule.
Subjects will receive a reasonable compensation per completed study visit. The
compensation includes the costs related to travelling to the study centre.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Age 60 - 80 years (both inclusive)
- BMI from 20 through 30 kg/m2
- Willingness and ability to comply with the protocol
- Written informed consent
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 >= 7.0 mmol/L)
- (History of) any cancer with the exception of basal cell carcinoma
- Fever (>38.5 C) 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 |
|---|---|
| CCMO | NL55300.072.15 |