No registrations found.
ID
Source
Brief title
Health condition
Malnutrition
Ondervoeding
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerance:
1. Daily stool frequency and consistency;
2. Occurrence and intensity of gastrointestinal symptoms.
Secondary outcome
Product appreciation: Product appreciation questionnaire.
Background summary
In this trial a new high energy product with vitamins, minerals and protein will be compared with standard high energy product on tolerance in subjects in need of high caloric oral nutritional support.
Study objective
Tolerance to new high energy product with vitamins, minerals and protein is equal to standard high energy product.
Study design
Screening, Baseline, week 1, week 2, week 3, week 4, Follow Up.
Intervention
Duration of intervention: 28 days.
1. Intervention group: New high energy product with vitamins, minerals and protein;
2. Control group: Standard high energy product.
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. Subjects (male/female) ≥ 18 years of age at the start of the Baseline period;
2. Subject is prescribed high caloric oral nutritional support (subject can be current or new user);
3. In case of new users: MUST (Malnutrition Universal Screening Tool) score 1 (medium risk of malnutrition), or 2 or more (high risk of malnutrition);
4. Subject is expected to require high caloric 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
1. Known inflammatory bowel disease (e.g. Crohn's disease);
2. Pancreatitis or illness with known fat malabsorption;
3. Exposure to chemotherapy concomitantly or within two weeks prior to entry into the study;
4. Life expectancy of ≤ 3 months;
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. Ileostomy or colostomy;
8. Known galactosaemia;
9. Know cow's milk allergy;
10. Parenteral feeding;
11. Tube feeding;
12. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
13. Participation in any other study 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 | NL2783 |
NTR-old | NTR2923 |
Other | Danone Research ¨C Centre for Specialised Nutrition : Cal.1.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |