It is hypothesized that the outcome of the primary outcome parameter will be different for the test product compared to the control product.
ID
Bron
Verkorte titel
Aandoening
Gastrointestinal tolerance in healthy volunteers in which gastric conditions of critically ill patients will be mimicked by medication.
Ondersteuning
Uppsalalaan 12,
3508 CT Utrecht – the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Gastric content volume
Achtergrond van het onderzoek
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.
Doel van het onderzoek
It is hypothesized that the outcome of the primary outcome parameter will be different for the test product compared to the control product.
Onderzoeksopzet
V0 (screening day -21 until day -4); V1 (day 1); V2 (day 15)
Onderzoeksproduct en/of interventie
Duration of intervention: 4 hours
Intervention product: whey dominant tube feed
Control product: casein dominant tube feed
Publiek
Peter van Horssen
Utrecht 3508 CT
The Netherlands
T: +31 (0)30 2095000
Peter.vanhorssen@nutricia.com
Wetenschappelijk
Peter van Horssen
Utrecht 3508 CT
The Netherlands
T: +31 (0)30 2095000
Peter.vanhorssen@nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
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 | NL6243 |
| NTR-old | NTR6423 |
| Ander register | Commissie Medische Ethiek UZ KU Leuven : S59976 |