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ID
Source
Brief title
Health condition
Malnutrition
Ondervoeding
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerance:
1. Daily stool frequency and consistency;
2. Incidence and intensity of gastrointestinal symptoms.
Secondary outcome
Intake and safety.
Background summary
In this trial a new high-energy high-protein oral nutritional supplement will be compared with standard high-energy high-protein oral nutritional supplement on tolerance in elderly subjects in need of oral nutritional support.
Study objective
Tolerance to new high-energy high-protein oral nutritional supplement is equal to standard high-energy high-protein oral nutritional supplement.
Study design
Screening, Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, Follow-up.
Intervention
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.
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2449 |
NTR-old | NTR2565 |
Other | Danone Research : Sip.4.C/C |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |