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Trial to evaluate tolerance and safety of a new pre-thickened sip feed in subjects in need of oral nutritional support.


- candidate number5224
- NTR NumberNTR1643
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2009
- Secondary IDsSip.5.c/a sponsor
- Public TitleTrial to evaluate tolerance and safety of a new pre-thickened sip feed in subjects in need of oral nutritional support.
- Scientific TitleRandomised controlled open label trial to evaluate tolerance and safety of a new pre-thickened energy dense sip feed in subjects in need of oral nutritional support.
- ACRONYMTOAD (Tolerance Of A Dysphagia pre-thickened sip feed)
- hypothesisIt is expected that the new pre-thickened sip feed is as safe as and well-tolerated as standard sip feed thickened with a commercially available thickener.
- Healt Condition(s) or Problem(s) studiedDysphagia, Malnutrition
- Inclusion criteria1. Male or female adult at least 18 years of age;
2. Subject is prescribed oral nutritional support of at least 300 kcal/day of energy enriched sip feed;
3. In case of new users: MUST score 1 (medium risk), or 2 or more (high risk);
4. Subject requires oral nutritional support for at least 4 weeks;
5. Written informed consent from subject.
- Exclusion criteria1. Known inflammatory bowel diseases (e.g. Crohns disease);
2. Known lactose intolerance and not using lactase;
3. Known galactosemia;
4. Major hepatic or renal dysfunction;
5. Subject with an ileostomy or colostomy;
6. Strong dislike of the flavours to be tested;
7. Requirement for oral nutritional support other than (thickened) energy enriched sip feeds (e.g. high protein sip feeds, disease specific sip feeds);
8. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
9. 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/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate30-sep-2009
- Target number of participants50
- InterventionsAfter randomisation, patients will receive either the pre-thickened sip feed or a standard sip feed thickened with a commercially available thickening powder for 28 days. Measurements of weight, stool frequency, GI symptoms, food & fluid intake, and product appreciation during the study period using stool records, GI questionnaires, dietary records and product appreciation questionnaires. Blood samples will be taken and analysed at Baseline, Day 14, and Day 28.
- Primary outcome1. Stool frequency;
2. Incidence and intensity of gastrointestinal symptoms;
3. Safety parameters in blood.
- Secondary outcomeStudy product intake (compliance).
- Timepoints1. Visit 1: screening;
2. Visit 2: baseline (day 0);
3. Visit 3: day 14;
4. Visit 4: day 28 (end of intervention);
5. Follow-up visit or phone call after 3 days.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc G. Wijhe, van
- CONTACT for SCIENTIFIC QUERIESDr. A. Vriesema
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn this study tolerance and safety of a pre-thickened sip feed will be compared to a standard sip feed, thickened with a commercially available thickener in subjects in need of oral nutritional support. Subjects will be using the product for 4 weeks.
- Main changes (audit trail)
- RECORD28-jan-2009 - 9-sep-2009


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