No registrations found.
ID
Source
Brief title
Health condition
Healthy male volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Enteral feeding is the preferred method of nutritional support in patients who have a functioning gastrointestinal (GI) tract but cannot maintain an adequate oral intake. There are various ways of administrating EN. The consequences of gastric or jejunal feeding with respect to changes in levels of amino acids (AA) and serving the nutritional requirements of the patient are currently unknown. Therefore, it is proposed that the differences in the responses to gastric and jejunal feeding with a main focus on digestion and absorption of AA will be determined.
Study objective
Gastric feeding, in an intact GI tract, will initiate a more physiological response than jejunal feeding.
Study design
The duration of the study for each subject from randomisation to the end of the study ideally is 6 weeks. In the first 5 weeks the subject will be admitted 2 times for 3 days, with a 4 week interval. Follow-up includes a phone call 1 week after every visit.
Intervention
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 cross-over study each healthy subject participates in 2 visits, with a minimal washout period of 4 weeks in between. Subjects are randomly assigned to one of two groups by a computer randomization program. Group I receives the first visit enteral nutrition (EN) through a naso-gastric tube and the second visit through a naso-jejunal tube and group II receives EN in opposite order.
X-ray abdomen with contrast to confirm position of tube. Venous canula in forearm or dorsal vein. Applying continuous glucose monitor system.
Barbara Mourmans
Wageningen 6700 CA
The Netherlands
+31 (0)31 7467800
barbara.mourmans@danone.com
Barbara Mourmans
Wageningen 6700 CA
The Netherlands
+31 (0)31 7467800
barbara.mourmans@danone.com
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
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
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 | NL2673 |
| NTR-old | NTR2801 |
| Other | Danone Research, Centre for Specialised Nutrition : COA.1.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |