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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00712-53 | Other Identifier | ANSM |
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Stop funding by Regional Council of Auvergne-Rhône-Alpes, France
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| Name | Class |
|---|---|
| Bioparhom, France | UNKNOWN |
| Regional Council of Auvergne-Rhône-Alpes | OTHER |
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Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.
Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.
In this study, three arms will be studied for 3 months: 1 control group, 1 group with whey supplementation at lunch, and 1 group with whey supplementation at lunch and an energy bolus before bedtime. Actions include weight and body composition monitoring, nutritional status and muscle function, as well as mechanistic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Patients will be randomized in the control group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis and Dual Energy X-ray Absorptiometry (DEXA). | |
| protein group | Experimental | Patients will be randomized in the protein group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein. |
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| protein and carbohydrates group | Experimental | Patients will be randomized in the protein and carbohydrates group. They will have test MNA (Mini Nutritional Assessment), frailty screening tool (questionnaire FiND), clinical examination, blood sample, blood sample with heparin, white blood cells, urine sample, stool sample, maximal voluntary contraction of quadriceps, walking test, get up-and-go test, Hand Grip test, physical activity questionnaire, bioelectrical impedance analysis, Dual Energy X-ray Absorptiometry (DEXA) and protein and carbohydrates. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein | Dietary Supplement | In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Appendicular lean body mass (gramme) | Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA). | Days 0 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| total body composition | Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition. | Days 0, 45 and 90 |
| Plasma albumin level (g/l) |
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Inclusion Criteria:
Resident on the Accommodation Establishments for Dependent Elderly Persons on the Mutuality of Loire, France
Risk of undernutrition or moderate undernutrition with one of the following criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio POLAKOF, PhD | UMR 1019, INRA, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EHPAD Cité des Aînés | Saint-Etienne | France | ||||
| EHPAD La Cerisaie |
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| Protein and Carbohydrate | Dietary Supplement | In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days and eat 60g of carbohydrates 2h after every diner during 90 days. |
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blood sample.
| Days 0, 45 and 90 |
| Frailty screening tool | Determination of fragility status. 3 status : Dependent, Fragile, Robust | Days 0 and 90 |
| Mini Nutritional Assessment score | Determine nutritional status. Score : 0-30 | Days 0 and 90 |
| Inflammatory status | Analysis of inflammatory status by blood sample results. C-reactive protein (CRP), Interleukin 6 (IL-6), Tumor necrosis factor (TNFα), monocyte chemoattractant protein 1 (MCP1) | Days 0, 45 and 90 |
| Hand Grip test (N) | Analysis of muscle function tests. | Days 0 and 90 |
| 6 minutes walk test (m) | Analysis of muscle function tests. | Days 0 and 90 |
| Maximal voluntary contraction of quadriceps (N) | Analysis of muscle function tests. | Days 0 and 90 |
| Get up-and-go test (s) | Analysis of muscle function tests. | Days 0 and 90 |
| Profiles of the differential expression of potentials biomarkers | Analysis of profiles of the differential expression of potentials biomarkers by results of blood sample with heparin, urine sample and white blood cells. | Days 0, 45 and 90 |
| microbiota | Analysis of microbiota by stool sample results. | Days 0 and 90 |
| Saint-Etienne |
| France |
| EHPAD Le Soleil | Saint-Etienne | France |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| D002241 | Carbohydrates |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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