Randomised controlled trial to evaluate tolerance, intake and safety of a new high-energy high-protein oral nutritional supplement in elderly subjects in need of oral nutritional support.
Completed
- Conditions
- MalnutritionOndervoeding
- Registration Number
- NL-OMON26236
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
Inclusion Criteria
1. Male/female subjects ≥ 65 years of age;
2. Subject is in need of oral nutritional support of ≥ 300 kcal/day;
Exclusion Criteria
1. Known inflammatory bowel disease (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:<br /><br>1. Daily stool frequency and consistency;<br /><br>2. Incidence and intensity of gastrointestinal symptoms.
- Secondary Outcome Measures
Name Time Method Intake and safety.