Clinical trial NCT02117609: Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
Official title: Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malnutrition
Keywords: Elderly
Nursing home
Functional impairment
High-protein oral supplement
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Toulouse
name: University of Lille Nord de France
name: National Research Agency, France
First posted: 2014-04-21
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in 4-meter walking speed
timeFrame: After 3 months and 6 months
Secondary outcomes:
measure: Change from baseline in grip strength
timeFrame: After 3 months and 6 months
measure: Change from baseline in ADL (Activities Daily Living) score
timeFrame: After 3 months and 6 months
measure: Change from baseline in Geriatric Depression Scale
timeFrame: After 3 months and 6 months
measure: Change from baseline in quality of life (QOL-AD)
timeFrame: After 3 months and 6 months
measure: Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)
timeFrame: During the 3 months and/or 6 months of consumption
measure: Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)
timeFrame: After 3 months and 6 months
measure: Change from baseline in nutritional status (Mini Nutritional Assessment)
timeFrame: After 3 months and 6 months
measure: Changes from baseline in blood parameters
timeFrame: After 3 months and 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Nursing homes - Région Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: Yves Rolland, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Lactalis Nutrition Santé
name: Cécile Bonhomme, PhD
role: STUDY_DIRECTOR
affiliation: U995, Université Lille Nord France
name: David Seguy, Dr
role: STUDY_CHAIR
affiliation: Lactalis Recherche et Développement
name: Charlotte Baudry, PhD
role: STUDY_CHAIR
References: