Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
Phase 2
Completed
- Conditions
- Malnutrition
- Registration Number
- NCT02117609
- Lead Sponsor
- Lactalis
- Brief Summary
The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- Man or woman aged more than 60 years old
- Living in a nursing home for at least 2 months
- Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months)
- Without dementia or with moderate dementia (MMSE > or =10/30)
- Able to walk without human assistance (technical assistance allowed)
- No vitamin D supplementation
- Able to follow the study procedures and agreed to consume oral supplement
Exclusion Criteria
- Severe dementia (MMSE < 10/30)
- Enteral nutrition
- Severe renal or hepatic impairment
- Cancer with chemotherapy
- Uncontrolled diabetes
- Lactose intolerance
- Cow's milk protein allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in 4-meter walking speed After 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Change from baseline in Geriatric Depression Scale After 3 months and 6 months Change from baseline in grip strength After 3 months and 6 months Change from baseline in body composition measured by bioelectrical impedence analysis (BIA) After 3 months and 6 months Change from baseline in nutritional status (Mini Nutritional Assessment) After 3 months and 6 months Change from baseline in ADL (Activities Daily Living) score After 3 months and 6 months Change from baseline in quality of life (QOL-AD) After 3 months and 6 months Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization) During the 3 months and/or 6 months of consumption Changes from baseline in blood parameters After 3 months and 6 months Inflammation markers (TNFalpha, TNF-R1, TNF-R2, IL 15), Fatty acid composition of red blood cell membranes, Fibrinogen, CRP, albumin, prealbumin, orosomucoid, IGF-1, cystein, glutathione peroxidase, oxidized and reduced glutathione
Trial Locations
- Locations (1)
Nursing homes - Région Midi-Pyrénées
🇫🇷Toulouse, France
Nursing homes - Région Midi-Pyrénées🇫🇷Toulouse, France