Clinical trial NCT03867006: Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
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
Overall status: TERMINATED
Phase: NA
Conditions: Undernutrition
Keywords: Malnutrition
Undernutrition
Elderly
Protein
Carbohydrate
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Bioparhom, France
name: Regional Council of Auvergne-Rhône-Alpes
First posted: 2019-03-07
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Appendicular lean body mass (gramme)
timeFrame: Days 0 and 90
Secondary outcomes:
measure: total body composition
timeFrame: Days 0, 45 and 90
measure: Plasma albumin level (g/l)
timeFrame: Days 0, 45 and 90
measure: Frailty screening tool
timeFrame: Days 0 and 90
measure: Mini Nutritional Assessment score
timeFrame: Days 0 and 90
measure: Inflammatory status
timeFrame: Days 0, 45 and 90
measure: Hand Grip test (N)
timeFrame: Days 0 and 90
measure: 6 minutes walk test (m)
timeFrame: Days 0 and 90
measure: Maximal voluntary contraction of quadriceps (N)
timeFrame: Days 0 and 90
measure: Get up-and-go test (s)
timeFrame: Days 0 and 90
measure: Profiles of the differential expression of potentials biomarkers
timeFrame: Days 0, 45 and 90
measure: microbiota
timeFrame: Days 0 and 90
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: EHPAD Cité des Aînés
city: Saint-Étienne
country: France
facility: EHPAD La Cerisaie
city: Saint-Étienne
country: France
facility: EHPAD Le Soleil
Study officials:
affiliation: UMR 1019, INRA, France
name: Sergio POLAKOF, PhD
role: STUDY_DIRECTOR
References: