No registrations found.
ID
Source
Brief title
Health condition
Healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter in this study is gastric emptying time derived from a mathematical gastric emptying model (MRI).
Secondary outcome
1. Gastric emptying time measured with 13C breath test;
2. Changes in postprandial plasma amino acid profile;
3. Volume and dynamics of gastric secretions;
4. Intragastric distribution and macrostructural changes of the meal;
5. Gastrointestinal symptoms (heartburn, satiety, belching, nausea, vomiting, abdominal distension);
6. Changes in postprandial plasma glucose profiles.
Background summary
In this study the gastric emptying rate of 3 different enteral nutrition products will be investigated.
Study objective
The primary hypothesis is that tube feeds with different protein sources will have different gastric emptying rates.
Study design
T = 0, 5, 10, 15, 20, 30, 50, 65, 80, 135 and 185 minutes.
Intervention
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.
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
P.O. Box 7005
M. Klebach
Wageningen 6700 CA
The Netherlands
marianne.klebach@danone.com
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL2838 |
| NTR-old | NTR2979 |
| Other | Danone Research - Center for Specialised Nutrition : Tub.1.C.B |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |