Tolerance to new high energy product with vitamins, minerals and protein is equal to standard high energy product.
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. Occurrence and intensity of gastrointestinal symptoms.
Achtergrond van het onderzoek
In this trial a new high energy product with vitamins, minerals and protein will be compared with standard high energy product on tolerance in subjects in need of high caloric oral nutritional support.
Doel van het onderzoek
Tolerance to new high energy product with vitamins, minerals and protein is equal to standard high energy product.
Onderzoeksopzet
Screening, Baseline, week 1, week 2, week 3, week 4, Follow Up.
Onderzoeksproduct en/of interventie
Duration of intervention: 28 days.
1. Intervention group: New high energy product with vitamins, minerals and protein;
2. Control group: Standard high energy product.
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. Subjects (male/female) ≥ 18 years of age at the start of the Baseline period;
2. Subject is prescribed high caloric oral nutritional support (subject can be current or new user);
3. In case of new users: MUST (Malnutrition Universal Screening Tool) score 1 (medium risk of malnutrition), or 2 or more (high risk of malnutrition);
4. Subject is expected to require high caloric 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known inflammatory bowel disease (e.g. Crohn's disease);
2. Pancreatitis or illness with known fat malabsorption;
3. Exposure to chemotherapy concomitantly or within two weeks prior to entry into the study;
4. Life expectancy of ≤ 3 months;
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. Ileostomy or colostomy;
8. Known galactosaemia;
9. Know cow's milk allergy;
10. Parenteral feeding;
11. Tube feeding;
12. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
13. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2783 |
NTR-old | NTR2923 |
Ander register | Danone Research ¨C Centre for Specialised Nutrition : Cal.1.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |