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

NCT ID: NCT03867006

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2022-10-31

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.

Conditions

Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Protein

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

Protein and Carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Protein

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioparhom, France

UNKNOWN

Sponsor Role: collaborator

Regional Council of Auvergne-Rhône-Alpes

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergio POLAKOF, PhD

Role: STUDY_DIRECTOR

UMR 1019, INRA, France

Locations

EHPAD Cité des Aînés

Saint-Etienne, , France

EHPAD La Cerisaie

Saint-Etienne, , France

EHPAD Le Soleil

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-A00712-53

Identifier Type: OTHER

Identifier Source: secondary_id

18CH036

Identifier Type: -

Identifier Source: org_study_id