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

Danone Research - Centre for Specialised Nutrition0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Age range: 18 - 45 years
•Understanding of the Dutch language
•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

•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

发起方

Danone Research - Centre for Specialised Nutrition