Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANR ALIA2010-01306 Presage | Other Grant/Funding Number | National Research Organization, France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Toulouse | OTHER |
| University of Lille Nord de France | OTHER |
| National Research Agency, France | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New DELICAL formula | Experimental | New high-protein oral nutrient supplement |
|
| Standard DELICAL formula | Active Comparator | Standard isoenergetic isoprotein formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New DELICAL formula | Dietary Supplement | 3 months with the option of continuing until 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 4-meter walking speed | After 3 months and 6 months |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yves Rolland, Pr | University Hospital, Toulouse | Principal Investigator |
| Cécile Bonhomme, PhD | Lactalis Nutrition Santé | Study Director |
| David Seguy, Dr | U995, Université Lille Nord France | Study Chair |
| Charlotte Baudry, PhD | Lactalis Recherche et Développement | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursing homes - Région Midi-Pyrénées | Toulouse | France |
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard DELICAL formula | Dietary Supplement | 3 months with the option of continuing until 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 |