None listed
Conditions
Interventions
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
Sponsors
Danone Research B.V.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stool frequency; 2. Incidence and intensity of gastrointestinal symptoms; 3. Safety parameters in blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study product intake (compliance). | — |
Contacts
Public ContactG. Wijhe, van
P.O. Box 7005
Outcome results
None listed