The primary hypothesis is that tube feeds with different protein sources will have different gastric emptying rates.
ID
Bron
Verkorte titel
Aandoening
Healthy volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary parameter in this study is gastric emptying time derived from a mathematical gastric emptying model (MRI).
Achtergrond van het onderzoek
In this study the gastric emptying rate of 3 different enteral nutrition products will be investigated.
Doel van het onderzoek
The primary hypothesis is that tube feeds with different protein sources will have different gastric emptying rates.
Onderzoeksopzet
T = 0, 5, 10, 15, 20, 30, 50, 65, 80, 135 and 185 minutes.
Onderzoeksproduct en/of interventie
A single bolus of 300 ml tube feed product will be administered in the stomach with a nasogastric tube. Each subject will receive 3 isocaloric tube feeds with different protein sources in randomized order at 3 separate visits. Repeated MRI scans of the stomach will be done during 185 minutes after product administration. Gastric emptying time will be compared between the 3 products.
Publiek
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Wetenschappelijk
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy subjects (male/female);
2. Age between 18 and 50;
3. BMI between 18 and 25 kg/m2;
4. Written informed consent from subject.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse;
2. Anemia (Hb < 7.5 mmol/l);
3. Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs;
4. Known galactosemia;
5. Known allergy to one or more of the product ingredients;
6. Positive Helicobacter pylori status;
7. Prior abdominal surgery other than uncomplicated appendectomy or hernia repair;
8. Presence of implants, devices or metallic foreign bodies that might interact with the MRI;
9. Claustrophobia;
10. Pregnancy and lactation.
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 | NL2838 |
| NTR-old | NTR2979 |
| Ander register | Danone Research - Center for Specialised Nutrition : Tub.1.C.B |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |