Randomised controlled trial to evaluate tolerance of a new fibre-enriched sip feed in subjects in need of oral nutritional support.
- Conditions
- Malnutrition
- Registration Number
- NL-OMON26327
- Lead Sponsor
- Danone Research – Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Subjects (male/female) ≥ 50 years of age at the start of the Baseline period;
2. Subject is prescribed oral nutritional support of 300 kcal/day of sip feed (subject can be current or new user);
Exclusion Criteria
1. Known inflammatory bowel diseases (e.g. Crohn’s disease);
2. Known lactose intolerance and not using lactase;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerance, daily:<br /><br>1. Stool frequency;<br /><br>2. Incidence of liquid stools;<br /><br>3. Incidence and intensity gastrointestinal symptoms.<br>
- Secondary Outcome Measures
Name Time Method 1. Study product intake;<br /><br>2. Product appreciation.<br>