Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
- Conditions
- Undernutrition
- Interventions
- Dietary Supplement: ProteinDietary Supplement: Protein and Carbohydrate
- Registration Number
- NCT03867006
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description protein group Protein 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. protein and carbohydrates group Protein and Carbohydrate 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.
- Primary Outcome Measures
Name Time Method Appendicular lean body mass (gramme) Days 0 and 90 Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA).
- Secondary Outcome Measures
Name Time Method Inflammatory status Days 0, 45 and 90 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)
Plasma albumin level (g/l) Days 0, 45 and 90 blood sample.
Get up-and-go test (s) Days 0 and 90 Analysis of muscle function tests.
Frailty screening tool Days 0 and 90 Determination of fragility status. 3 status : Dependent, Fragile, Robust
6 minutes walk test (m) Days 0 and 90 Analysis of muscle function tests.
Profiles of the differential expression of potentials biomarkers Days 0, 45 and 90 Analysis of profiles of the differential expression of potentials biomarkers by results of blood sample with heparin, urine sample and white blood cells.
microbiota Days 0 and 90 Analysis of microbiota by stool sample results.
total body composition Days 0, 45 and 90 Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition.
Mini Nutritional Assessment score Days 0 and 90 Determine nutritional status. Score : 0-30
Hand Grip test (N) Days 0 and 90 Analysis of muscle function tests.
Maximal voluntary contraction of quadriceps (N) Days 0 and 90 Analysis of muscle function tests.
Trial Locations
- Locations (3)
EHPAD Cité des Aînés
🇫🇷Saint-Étienne, France
EHPAD La Cerisaie
🇫🇷Saint-Étienne, France
EHPAD Le Soleil
🇫🇷Saint-Étienne, France