No registrations found.
ID
Source
Brief title
Health condition
Gastrointestinal tolerance in healthy volunteers in which gastric conditions of critically ill patients will be mimicked by medication.
Sponsors and support
Uppsalalaan 12,
3508 CT Utrecht – the Netherlands
Intervention
Outcome measures
Primary outcome
Gastric content volume
Secondary outcome
Plasma amino acid concentrations
Background summary
This study will investigate the effect of composition of enteral feeding on gastric content volume during continuous feeding. The study will be a randomized, controlled, open label, cross-over, single centre study. The study will be performed in healthy volunteers in which gastric conditions of critically ill patients will be mimicked by medication. Subjects will be continuously fed for 4-hours with the intervention product (whey dominant tube feed) or control product (casein dominant tube feed). Before, during and after feeding the gastric content volume will be studied.
Study objective
It is hypothesized that the outcome of the primary outcome parameter will be different for the test product compared to the control product.
Study design
V0 (screening day -21 until day -4); V1 (day 1); V2 (day 15)
Intervention
Duration of intervention: 4 hours
Intervention product: whey dominant tube feed
Control product: casein dominant tube feed
Peter van Horssen
Utrecht 3508 CT
The Netherlands
T: +31 (0)30 2095000
Peter.vanhorssen@nutricia.com
Peter van Horssen
Utrecht 3508 CT
The Netherlands
T: +31 (0)30 2095000
Peter.vanhorssen@nutricia.com
Inclusion criteria
Main inclusion criteria
1. Age between 18 and 50 (including 18 and 50) years
2. Being in good health as to the judgement of the investigator
3. Written informed consent
Exclusion criteria
Main exclusion criteria
1. Known history of any disorders such as; gastrointestinal (GI), cardiovascular, respiratory, hematological, renal, hepatic, hypothyroidism, psychiatric panic attacks and/or diabetes mellitus and/or a history of brain tumor, an enlarged prostate or urination problems and/or recent head injury
2. Presence of implants, devices, or metallic foreign bodies interacting with MRI
3. A low systolic blood pressure (<100 mm Hg) in supine position
4. Pregnancy or breastfeeding
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 | NL6243 |
| NTR-old | NTR6423 |
| Other | Commissie Medische Ethiek UZ KU Leuven : S59976 |