Malnutrition Ondervoeding
Conditions
Interventions
Duration of intervention: 56 days.
1. Intervention group: New high-energy high-protein oral nutritional supplement
2. Control group: Standard high-energy high-protein oral nutritional supplement.
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance: 1. Daily stool frequency and consistency; 2. Incidence and intensity of gastrointestinal symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intake and safety. | — |
Contacts
Public ContactMarjolein Vossers
Danone Research - Centre for Specialised Nutrition P.O.Box 7005
Outcome results
None listed