Malnutrition
Conditions
Interventions
Intervention group: new fibre-enriched sip feed
Control group: standard fibre-enriched sip feed.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects (male/female) ≥ 50 years of age at the start of the Baseline period; 2. Subject is prescribed oral nutritional support of  300 kcal/day of sip feed (subject can be current or new user); 3. In case of new users: MUST score 1 (medium risk of malnutrition), or 2 or more (high risk of malnutrition); 4. Subject is expected to require oral nutritional support for at least 4 weeks; 5. Subject has given written informed consent; 6. Subject is able to comply with the protocol (e.g. answer questions).
Exclusion criteria
Exclusion criteria: 1. Known inflammatory bowel diseases (e.g. Crohn’s disease); 2. Known lactose intolerance and not using lactase; 3. Known galactosemia; 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 major renal dysfunction: symptomatic renal dysfunction, previous serum creatinine level more than 1.8 times upper limit of normal, or requiring dialysis; 7. Subject with an ileostomy or colostomy; 8. Parenteral feeding; 9. Tube feeding; 10. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 11. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance, daily: 1. Stool frequency; 2. Incidence of liquid stools; 3. Incidence and intensity gastrointestinal symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Study product intake; 2. Product appreciation. | — |
Contacts
Public ContactMarjolein Miltenburg, van
PO Box 7005
Outcome results
None listed