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

NCT03867006 | Terminated

• 2 other identifiers: 18CH0362018-A00712-53
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Undernutrition

Keywords

Malnutrition; Undernutrition; Elderly; Protein; Carbohydrate

Outcome Measures

Primary Outcomes (1)

• 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).

  Days 0 and 90

Secondary Outcomes (11)

• total body composition

  Days 0, 45 and 90

• Plasma albumin level (g/l)

  Days 0, 45 and 90

• Frailty screening tool

  Days 0 and 90

• Mini Nutritional Assessment score

  Days 0 and 90

• Inflammatory status

  Days 0, 45 and 90

Study Arms (3)

control group

NO INTERVENTION

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

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

protein and carbohydrates group

EXPERIMENTAL

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

Interventions

Protein DIETARY_SUPPLEMENT

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

protein group

Protein and Carbohydrate 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.

protein and carbohydrates group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Bioparhom, France: collaborator
• Regional Council of Auvergne-Rhône-Alpes: collaborator

Study Sites (3)

EHPAD Cité des Aînés

Saint-Etienne, France

Location

EHPAD La Cerisaie

Saint-Etienne, France

Location

EHPAD Le Soleil

Saint-Etienne, France

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Proteins; Carbohydrates

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Sergio POLAKOF, PhD

  UMR 1019, INRA, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: March 7, 2019
• Study Start: February 8, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)