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

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.

Study Overview

• Status: Terminated
• Conditions: Undernutrition
• Intervention / Treatment: Dietary supplement: Protein; Dietary supplement: Protein and Carbohydrate

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric ROCHE, PhD; Phone Number: +33 (0)477829109; Email: frederic.roche@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • EHPAD Cité des Aînés
  • Saint-Étienne, France
    • EHPAD La Cerisaie
  • Saint-Étienne, France
    • EHPAD Le Soleil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total body composition	Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition.	Days 0, 45 and 90
Plasma albumin level (g/l)	blood sample.	Days 0, 45 and 90
Frailty screening tool	Determination of fragility status. 3 status : Dependent, Fragile, Robust	Days 0 and 90
Mini Nutritional Assessment score	Determine nutritional status. Score : 0-30	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)	Days 0, 45 and 90
Hand Grip test (N)	Analysis of muscle function tests.	Days 0 and 90
6 minutes walk test (m)	Analysis of muscle function tests.	Days 0 and 90
Maximal voluntary contraction of quadriceps (N)	Analysis of muscle function tests.	Days 0 and 90
Get up-and-go test (s)	Analysis of muscle function tests.	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.	Days 0, 45 and 90
microbiota	Analysis of microbiota by stool sample results.	Days 0 and 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Regional Council of Auvergne-Rhône-Alpes; Bioparhom, France
• Investigators: Study Director: Sergio POLAKOF, PhD, UMR 1019, INRA, France

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Malnutrition; Protein; Carbohydrate; Undernutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 18CH036; 2018-A00712-53 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No