Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: New DELICAL formula
* Dietary Supplement: Standard DELICAL formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New DELICAL formula<br>New high-protein oral nutrient supplement | Dietary Supplement: New DELICAL formula<br>* 3 months with the option of continuing until 6 months.<br>|
| Active Comparator: Standard DELICAL formula<br>Standard isoenergetic isoprotein formula | Dietary Supplement: Standard DELICAL formula<br>* 3 months with the option of continuing until 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 4-meter walking speed |  | After 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in grip strength |  | 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 Geriatric Depression Scale |  | 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 | 
| 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 | 
| Changes from baseline in blood parameters | 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 | After 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Nursing home, Functional impairment, High-protein oral supplement