Healthy male volunteers
Conditions
Interventions
A randomized, single-blind, single center, cross-over study. Study product (both groups): Nutritison Fiber during 12 h. Next day digestion and absorption test with labeled casein during 1 h. In this c
Sponsors
Danone Research – Centre for Specialised Nutrition; PO Box 7005, 6700 CA Wageningen; tel +31(0)317467800; fax +31(0)317466500
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age range: 18 < 45 years; 2. Sex: Male; 3. BMI range: 18 < 27 kg/m2; 4. Functioning gastrointestinal tract, eligible for tube feeding via an intestinal tube; 5. Willingness to comply with the study protocol, including: A. Use of standard breakfast day 1 of visit 1 and 2; B. Refrain from alcohol consumption 48h prior to, and during the assessments; C. Refrain from intense physical activities 48h prior to, and during the assessments; D. Refrain from antibiotics, NSAIDs and vitamins 2 weeks prior to, and during the assessments; E. Refrain from fish oil 4 weeks prior to, and during the assessments. 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any relevant gastrointestinal medical history, e.g.: A. Major gastrointestinal surgery; B. Gastrointestinal disease (e.g. gastric or paraesophagal hernia, gastrointestinal obstruction). 2. Heartburn Diabetes mellitus type I and II; 3. Hepatic or renal pathology; 4. Any relevant results of physical exam during screening defined as: A. Diastolic blood pressure ≥130mmHg; B. Abnormal heart souffle; C. Heart rhythm disorder; D. Abnormal respiratory sounds. 5. Any results of laboratory tests during screening other than the normal limit defined by the laboratory (Medial); 6. 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); 7. Smoking; 8. Alcohol abuse (defined as currently smoking or quit ≤ 6 months ago, > 21 units of alcohol a week); 9. Donor of blood the last 6 months; 10. Any other medical condition that may interfere with the safety of the subjects or the outcome parameters, in the investigator's judgment; 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol instructions; 12. 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 |
|---|---|
| Differences in digestion and absorption on the administration of enteral nutrition either gastric or distal to the ligament of Treitz in the jejunum. Primary parameter: Labeled phenylalanine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in endocrine responses to the administration of enteral nutrition either gastic or distal to the ligament of Treitz in the jejunum. Parameters: Amino acid profiles, hormone responses, Glucose, insulin, C-peptide response, Fatty acid profile, Folic acid, Vitamin B12, and iron. | — |
Contacts
Public ContactBarbara Mourmans
PO Box 7005
Outcome results
None listed