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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Undernutrition

Treatments: Dietary Supplement: Protein; Dietary Supplement: Protein and Carbohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03867006

2018-A00712-53 (Other Identifier)

18CH036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

control group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Dietary Supplement: Protein

protein and carbohydrates group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Protein and Carbohydrate