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Randomised controlled trial to evaluate tolerance of a new fibre-enriched sip feed in subjects in need of oral nutritional support.


- candidate number6724
- NTR NumberNTR2113
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2009
- Secondary IDsSip.7.C/A Danone Research – Centre for Specialised Nutrition
- Public TitleRandomised controlled trial to evaluate tolerance of a new fibre-enriched sip feed in subjects in need of oral nutritional support.
- Scientific TitleRandomised controlled trial to evaluate tolerance of a new fibre-enriched sip feed in subjects in need of oral nutritional support.
- ACRONYMCF trial
- hypothesisTolerance to new fibre-enriched sip feed is equal to standard fibre-enriched sip feed.
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate21-mei-2010
- Target number of participants50
- InterventionsDuration of intervention: 28 days;
Intervention group: new fibre-enriched sip feed;
Control group: standard fibre-enriched sip feed.
- Primary outcomeTolerance, daily:
1. Stool frequency;
2. Incidence of liquid stools;
3. Incidence and intensity gastrointestinal symptoms.
- Secondary outcome1. Study product intake;
2. Product appreciation.
- TimepointsScreening, Baseline, week 1, week 2, week 3, week 4 and Follow Up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marjolein Miltenburg, van
- CONTACT for SCIENTIFIC QUERIESDr. Rogier Anholt, van
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD17-nov-2009 - 4-dec-2009


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