An interventional study of Protein and Protein and Carbohydrate in Undernutrition, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 3 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 6 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Risk of undernutrition or moderate undernutrition with one of the following criteria :
Exclusion Criteria:
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).
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
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
In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
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.
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).
Time frame: Days 0 and 90
total body composition
Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition.
Time frame: Days 0, 45 and 90
Plasma albumin level (g/l)
blood sample.
Time frame: Days 0, 45 and 90
Frailty screening tool
Determination of fragility status. 3 status : Dependent, Fragile, Robust
Time frame: Days 0 and 90
Mini Nutritional Assessment score
Determine nutritional status. Score : 0-30
Time frame: 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)
Time frame: Days 0, 45 and 90
Hand Grip test (N)
Analysis of muscle function tests.
Time frame: Days 0 and 90
6 minutes walk test (m)
Analysis of muscle function tests.
Time frame: Days 0 and 90
Maximal voluntary contraction of quadriceps (N)
Analysis of muscle function tests.
Time frame: Days 0 and 90
Get up-and-go test (s)
Analysis of muscle function tests.
Time frame: 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.
Time frame: Days 0, 45 and 90
microbiota
Analysis of microbiota by stool sample results.
Time frame: Days 0 and 90
Plan to share: No
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This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne