Patienten die door hun aandoening of behandeling niet in staat zijn om aan hun voedingsbehoefte te voldoen Zie sectie J
Conditions
Interventions
Administration enteral nutrition on the stomach is compared to administrating
enterl nutrition distal of de ligament of Treitz in the jejunum.
The intervention is gastric feeding and jejunal feeding
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age range: 18 - 45 years Understanding of the Dutch language Sex: male BMI range: 18 - 27 kg/m2 Functioning gastrointestinal tract, eligible for tube feeding via an intestinal tube Willingness to comply with the study protocol, including: - Use of standard breakfast day 1 of visit 1 and 2 - Refrain from alcohol consumption 48h prior to, and during the assessments - Refrain from intense physical activities 48h prior to, and during the assessments - Refrain from antibiotics, NSAID*s and vitamins 2 weeks prior to, and during the assessments - Refrain from fish oil 4 weeks prior to, and during the assessments Written informed consent
Exclusion criteria
Exclusion criteria: Any relevant gastrointestinal medical history, e.g.: - Major gastrointestinal surgery - Gastrointestinal disease, e.g.: - Gastric or paraesophagal hernia - Gastrointestinal obstruction - Heartburn Diabetes mellitus type I and II Hepatic or renal pathology Any relevant results of physical exam during screening; defined as: - Diastolic blood pressure >=130mmHg - Abnormal heart souffle - Heart rhythm disorder - Abnormal respiratory sounds Any results of laboratory tests during screening other than the normal limit defined by the laboratory (Medial) Any relevant exclusion criteria listed on the product label; e.g.: - Subjects requiring a fibre-free diet Allergy / intolerance for the enteral nutrition Allergy / intolerance for contrast given during the abdominal X-ray Smoking, alcohol abuse; defined as: - Currently smoking or quit 21 units of alcohol a week Donor of blood the last 6 months Any other medical condition that may interfere with the safety of the subjects or the outcome parameters, in the investigator*s judgment Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol instructions Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter in this study is: - L-[1-13C]phenylalanine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters in this study are: - Amino acid profiles - Hormone responses: CCK, PYY, ghrelin, GLP-1*, GLP-2* - Glucose, insulin, C-peptide and glucagon response - D2-glucose* - Fatty acid profile in plasma - Folic acid, vitamin B12, and iron (* optional) Parameters on tolerance and safety in this study are: - Gastric residues by aspiration of gastric content with syringe (every 4h) - In case of a gastric residue >250 in presence of other signs of intolerance (ASPEN Guidelines 2009) - In case of a gastric residue >500ml in absence of other signs of intolerance (ASPEN Guidelines 2009) - Tolerance questionnaire (every 4h) - Liver function: AST, ALT, GGT - Kidney function: creatinine - Haematology: red blood cell count (RBC), white blood cell count (WBC), platelet count, haemoglobin (Hb) - CRP - Serum electrolytes: Na, K, Urea - (Serious) adverse events | — |
Countries
Netherlands
Outcome results
None listed