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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03867006

Collaborator

Bioparhom, France (Other), Regional Council of Auvergne-Rhône-Alpes (Other)

Enrollment

Locations

Arms

50.7

Anticipated Duration (Months)

8.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Undernutrition	Dietary Supplement: Protein Dietary Supplement: Protein and Carbohydrate	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 8, 2019

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group 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 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 In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
Experimental: protein and carbohydrates group 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 and eat 60g of carbohydrates 2h after every diner during 90 days.

Arm

Intervention/Treatment

No Intervention: control group

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

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

In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.

Experimental: protein and carbohydrates group

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 and eat 60g of carbohydrates 2h after every diner during 90 days.

Outcome Measures

Primary Outcome Measures

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

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.
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.
6 minutes walk test (m) [Days 0 and 90]
Analysis of muscle function tests.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	EHPAD L'Adret	Bellegarde-en-Forez	France
2	EHPAD Les Myosotis	L'Horme	France	42110
3	EHPAD Les Tilleuls	La Grand-Croix	France
4	EHPAD Le Val Dorlay	Saint-Paul-en-Jarez	France
5	Chu Saint-Etienne	Saint-Étienne	France
6	EHPAD Bellevue	Saint-Étienne	France
7	EHPAD Bernadette	Saint-Étienne	France
8	EHPAD Cité des Aînés	Saint-Étienne	France
9	EHPAD La Cerisaie	Saint-Étienne	France
10	EHPAD Le Soleil	Saint-Étienne	France
11	EHPAD Valbenoite	Saint-Étienne	France