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.
Completed
- Conditions
- MalnutritionOndervoeding
- Registration Number
- NL-OMON23160
- Lead Sponsor
- Danone Research ¨C Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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);
Exclusion Criteria
1. Known inflammatory bowel disease (e.g. Crohn's disease);
2. Pancreatitis or illness with known fat malabsorption;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance:<br /><br>1. Daily stool frequency and consistency;<br /><br>2. Occurrence and intensity of gastrointestinal symptoms.
- Secondary Outcome Measures
Name Time Method Product appreciation: Product appreciation questionnaire.