Healthy volunteers
Conditions
Interventions
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
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter in this study is gastric emptying time derived from a mathematical gastric emptying model (MRI). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactM. Klebach
Danone Research P.O. Box 7005
Outcome results
None listed