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Modulation of gastric function and protein assimilation by different proteins sources in enteral nutrition formulas.


- candidate number10122
- NTR NumberNTR2979
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2011
- Secondary IDsTub.1.C.B  Danone Research - Center for Specialised Nutrition
- Public TitleModulation of gastric function and protein assimilation by different proteins sources in enteral nutrition formulas.
- Scientific TitleModulation of gastric function and protein assimilation by different proteins sources in enteral nutrition formulas.
- ACRONYMFlow study
- hypothesisThe primary hypothesis is that tube feeds with different protein sources will have different gastric emptying rates.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-jul-2011
- planned closingdate1-feb-2012
- Target number of participants20
- InterventionsA 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.
- Primary outcomeThe primary parameter in this study is gastric emptying time derived from a mathematical gastric emptying model (MRI).
- Secondary outcome1. 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.
- TimepointsT = 0, 5, 10, 15, 20, 30, 50, 65, 80, 135 and 185 minutes.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M. Klebach
- CONTACT for SCIENTIFIC QUERIES Zandrie Hofman
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn this study the gastric emptying rate of 3 different enteral nutrition products will be investigated.
- Main changes (audit trail)
- RECORD8-jul-2011 - 12-dec-2011


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