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

Primary Purpose

Undernutrition

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protein
Protein and Carbohydrate
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Undernutrition focused on measuring Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • EHPAD Cité des Aînés
  • EHPAD La Cerisaie
  • EHPAD Le Soleil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

protein group

protein and carbohydrates group

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2018
Last Updated
April 14, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Bioparhom, France, Regional Council of Auvergne-Rhône-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT03867006
Brief Title
Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
Acronym
CARBOPTIMUS
Official Title
Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Stop funding by Regional Council of Auvergne-Rhône-Alpes, France
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Bioparhom, France, Regional Council of Auvergne-Rhône-Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
Malnutrition, Undernutrition, Elderly, Protein, Carbohydrate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm 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).
Arm Title
protein group
Arm Type
Experimental
Arm 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.
Arm Title
protein and carbohydrates group
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein and Carbohydrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appendicular lean body mass (gramme)
Description
Comparison appendicular lean body mass between the day of inclusion and 90 days after. It is measuring by Dual Energy X-ray Absorptiometry (DEXA).
Time Frame
Days 0 and 90
Secondary Outcome Measure Information:
Title
total body composition
Description
Correlation between Dual Energy X-ray Absorptiometry (DEXA) results and bioelectrical impedance analysis results to determine total body composition.
Time Frame
Days 0, 45 and 90
Title
Plasma albumin level (g/l)
Description
blood sample.
Time Frame
Days 0, 45 and 90
Title
Frailty screening tool
Description
Determination of fragility status. 3 status : Dependent, Fragile, Robust
Time Frame
Days 0 and 90
Title
Mini Nutritional Assessment score
Description
Determine nutritional status. Score : 0-30
Time Frame
Days 0 and 90
Title
Inflammatory status
Description
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)
Time Frame
Days 0, 45 and 90
Title
Hand Grip test (N)
Description
Analysis of muscle function tests.
Time Frame
Days 0 and 90
Title
6 minutes walk test (m)
Description
Analysis of muscle function tests.
Time Frame
Days 0 and 90
Title
Maximal voluntary contraction of quadriceps (N)
Description
Analysis of muscle function tests.
Time Frame
Days 0 and 90
Title
Get up-and-go test (s)
Description
Analysis of muscle function tests.
Time Frame
Days 0 and 90
Title
Profiles of the differential expression of potentials biomarkers
Description
Analysis of profiles of the differential expression of potentials biomarkers by results of blood sample with heparin, urine sample and white blood cells.
Time Frame
Days 0, 45 and 90
Title
microbiota
Description
Analysis of microbiota by stool sample results.
Time Frame
Days 0 and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio POLAKOF, PhD
Organizational Affiliation
UMR 1019, INRA, France
Official's Role
Study Director
Facility Information:
Facility Name
EHPAD Cité des Aînés
City
Saint-Étienne
Country
France
Facility Name
EHPAD La Cerisaie
City
Saint-Étienne
Country
France
Facility Name
EHPAD Le Soleil
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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