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.

Phase 2

Completed

Conditions: malnutrition
poor nutritional status
10003018

Registration Number: NL-OMON36680

Lead Sponsor: Danone Research - Centre for Specialised Nutrition

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is tolerance. Tolerance will be evaluated by measuring<br /><br>the following parameters:<br /><br>- Daily stool frequency and consistency<br /><br>- Tolerance questionnaire</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundairy parameters are safety and intake. These will be evaluated by<br /><br>measuring the following parameters:<br /><br>- Daily study product intake<br /><br>- Fluid intake<br /><br>- Occurrence of (Serious) Adverse Events<br /><br>- Blood parameters<br /><br>- Urine parameters<br /><br>- Paramters derived from blood and urine parameters<br /><br>- Blood pressure<br /><br>- Resting heart rate<br /><br><br /><br>Other parameters are:<br /><br>- Body weight<br /><br>- Body Mass Index<br /><br>- Dietary Intake<br /><br>- Product appreciation (for example taste).</p><br>