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

Undernutrition Clinical Trial

— CARBOPTIMUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03867006
• Other study ID #: 18CH036
• Secondary ID: 2018-A00712-53
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

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

Locations

Country	Name	City	State
France	EHPAD Cité des Aînés	Saint-Étienne
France	EHPAD La Cerisaie	Saint-Étienne
France	EHPAD Le Soleil	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Bioparhom, France, Regional Council of Auvergne-Rhône-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Plasma albumin level (g/l)	blood sample.	Days 0, 45 and 90
Secondary	Frailty screening tool	Determination of fragility status. 3 status : Dependent, Fragile, Robust	Days 0 and 90
Secondary	Mini Nutritional Assessment score	Determine nutritional status. Score : 0-30	Days 0 and 90
Secondary	Inflammatory status	Analysis of inflammatory status by blood sample results. C-reactive protein (CRP), Interleukin 6 (IL-6), Tumor necrosis factor (TNFa), monocyte chemoattractant protein 1 (MCP1)	Days 0, 45 and 90
Secondary	Hand Grip test (N)	Analysis of muscle function tests.	Days 0 and 90
Secondary	6 minutes walk test (m)	Analysis of muscle function tests.	Days 0 and 90
Secondary	Maximal voluntary contraction of quadriceps (N)	Analysis of muscle function tests.	Days 0 and 90
Secondary	Get up-and-go test (s)	Analysis of muscle function tests.	Days 0 and 90
Secondary	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
Secondary	microbiota	Analysis of microbiota by stool sample results.	Days 0 and 90