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Randomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support.


- candidate number8552
- NTR NumberNTR2565
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2010
- Secondary IDsSip.4.C/C  Danone Research
- Public TitleRandomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support.
- Scientific TitleRandomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support.
- ACRONYMCompass
- hypothesisTolerance to new high-energy high-protein oral nutritional supplement is equal to standard high-energy high-protein oral nutritional supplement.
- Healt Condition(s) or Problem(s) studiedMalnutrition
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-okt-2010
- planned closingdate30-jun-2011
- Target number of participants68
- InterventionsDuration 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.
- Primary outcomeTolerance:
1. Daily stool frequency and consistency;
2. Incidence and intensity of gastrointestinal symptoms.
- Secondary outcomeIntake and safety.
- TimepointsScreening, Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, Follow-up.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. Marjolein Vossers
- CONTACT for SCIENTIFIC QUERIESDr. A. Vriesema
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD12-okt-2010 - 11-aug-2012


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