Randomised controlled trial to evaluate tolerance of a new high energy product with vitamins, minerals and protein in subjects in need of high caloric oral nutritional support.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23160

Enrollment

Registered

2011-05-31

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Ondervoeding

Interventions

Duration of intervention: 28 days. 1. Intervention group: New high energy product with vitamins, minerals and protein

2. Control group: Standard high energy product.

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Tolerance: 1. Daily stool frequency and consistency; 2. Occurrence and intensity of gastrointestinal symptoms.	—

Secondary

Measure	Time frame
Product appreciation: Product appreciation questionnaire.	—

Contacts

Public ContactMarjolein Vossers

Danone Research - Centre for Specialised Nutrition P.O.Box 7005

marjolein.vossers@danone.com+31 (0)317 467955

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)