Gastric versus distal to the ligament of Treitz feeding in healthy volunteers

Phase 2

Completed

• Conditions: Patienten die door hun aandoening of behandeling niet in staat zijn om aan hun voedingsbehoefte te voldoen; Zie sectie J

• Registration Number: NL-OMON36348
• Lead Sponsor: Danone Research - Centre for Specialised Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

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 <=6 months ago
- > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter in this study is:<br /><br>- L-[1-13C]phenylalanine</p><br>