Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals

Conditions
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Undernutrition

Intervention / Treatment
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* Dietary Supplement: Protein
* Dietary Supplement: Protein and Carbohydrate


Participation Criteria
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Eligibility Criteria
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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 : Either 5-10% of weight loss in 1 month or 10-15% in 6 months. Or Body Mass Index (BMI) between 16 and 21 Or Albumin levels between 30 and 35 g/L Or global Mini Nutritional Assessment (MNA) test between 17 and 23.5 Or Short Emergency Geriatric Assessment (SEGA) Score >8 Exclusion Criteria: Sub-acute pathology (flu, gastroenteritis, bacterial infections ...) or trauma (fracture, surgery ...) in the 30 days prior to inclusion. Hepatocellular insufficiency Heart failure with decompensation Severe dementia, Insulin-treated diabetes Renal insufficiency (clearance <30 ml / min) Long-term cortico-therapy Cancer undergoing chemotherapy treatment or/and radiotherapy Gastrointestinal pathology, Diet incompatible with the nutritional protocol (intolerance to milk or lactose, vegetarians, vegans, ...) Motor disability leading to the impossibility of doing muscle function tests.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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). | |
| Experimental: protein group<br>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. | Dietary Supplement: Protein<br>* In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.<br>|
| Experimental: protein and carbohydrates group<br>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. | Dietary Supplement: Protein and Carbohydrate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate