Randomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support. - Compass

Danone Research - Centre for Specialised Nutrition0 个研究点目标入组 10 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。

•1. Male/female subjects >= 65 years of age
•2. Subject is in need of oral nutritional support of >= 300 kcal/day
•3. Subject is expected to require oral nutritional support for at least 8 weeks
•4. Subject has given written informed consent
•5. Subject is able to comply with the protocol (e.g. answer questions, collect urine)

•1. Known inflammatory bowel disease (e.g. Crohn*s disease)
•2. Known lactose intolerance and not using lactase
•3. Known galactosaemia
•4. Known cow*s milk allergy
•5. Known major hepatic dysfunction: symptomatic hepatic dysfunction or previous serum transaminase (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal
•6. Known renal dysfunction: symptomatic renal dysfunction or a previous GFR < 60 mL/min/1.73 m2 for longer than 3 months (stage 3 - stage 5 chronic kidney disease)
•7. Requirement of a protein restricted diet (such as for renal failure)
•8. Ileostomy or colostomy
•9. Parenteral feeding
•10. Tube feeding
•11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
•12. 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