Undernutrition
Conditions
Keywords
Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate
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.
Interventions
DIETARY_SUPPLEMENTProtein
In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
DIETARY_SUPPLEMENTProtein and Carbohydrate
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.
Sponsors
Bioparhom, France
Regional Council of Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma albumin level (g/l) | Days 0, 45 and 90 | blood sample. |
| Frailty screening tool | Days 0 and 90 | Determination of fragility status. 3 status : Dependent, Fragile, Robust |
| Mini Nutritional Assessment score | Days 0 and 90 | Determine nutritional status. Score : 0-30 |
| 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) |
| Hand Grip test (N) | Days 0 and 90 | Analysis of muscle function tests. |
| 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. |
| Maximal voluntary contraction of quadriceps (N) | Days 0 and 90 | Analysis of muscle function tests. |
| Get up-and-go test (s) | 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. |
| 6 minutes walk test (m) | Days 0 and 90 | Analysis of muscle function tests. |
Countries
France
Outcome results
None listed