No registrations found.
ID
Source
Brief title
Health condition
Malnutrition
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerance, daily:
1. Stool frequency;
2. Incidence of liquid stools;
3. Incidence and intensity gastrointestinal symptoms.
Secondary outcome
1. Study product intake;
2. Product appreciation.
Background summary
In this trial a new fibre-enriched sip feed will be compared with standard fibre-enriched sip feed on tolerance in subjects in need of nutritional support.
Study objective
Tolerance to new fibre-enriched sip feed is equal to standard fibre-enriched sip feed.
Study design
Screening, Baseline, week 1, week 2, week 3, week 4 and Follow Up.
Intervention
Duration of intervention: 28 days;
Intervention group: new fibre-enriched sip feed;
Control group: standard fibre-enriched sip feed.
Marjolein Miltenburg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
Marjolein.vanmiltenburg@danone.com
Marjolein Miltenburg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
Marjolein.vanmiltenburg@danone.com
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
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
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 | NL1996 |
NTR-old | NTR2113 |
Other | Danone Research – Centre for Specialised Nutrition : Sip.7.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |