It 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.
ID
Bron
Verkorte titel
Aandoening
-malnutrition
-dysphagia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Stool frequency;<br>
2. Incidence and intensity of gastrointestinal symptoms;<br>
3. Safety parameters in blood.
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
It 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.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
After 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.
Publiek
G. Wijhe, van
Wageningen 6700 CA
The Netherlands
+31 (0)317467957
gerda.vanwijhe@danone.com
Wetenschappelijk
G. Wijhe, van
Wageningen 6700 CA
The Netherlands
+31 (0)317467957
gerda.vanwijhe@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1563 |
| NTR-old | NTR1643 |
| Ander register | sponsor : Sip.5.c/a |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |