Tolerance to new high-energy high-protein oral nutritional supplement is equal to standard high-energy high-protein oral nutritional supplement.
ID
Bron
Verkorte titel
Aandoening
Malnutrition
Ondervoeding
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tolerance:<br>
1. Daily stool frequency and consistency;<br>
2. Incidence and intensity of gastrointestinal symptoms.
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Tolerance to new high-energy high-protein oral nutritional supplement is equal to standard high-energy high-protein oral nutritional supplement.
Onderzoeksopzet
Screening, Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, Follow-up.
Onderzoeksproduct en/of interventie
Duration 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.
Publiek
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
Wetenschappelijk
P.O.Box 7005
Marjolein Vossers
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467955
marjolein.vossers@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2449 |
NTR-old | NTR2565 |
Ander register | Danone Research : Sip.4.C/C |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |