Status:
TERMINATED
Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Bioparhom, France
Regional Council of Auvergne-Rhône-Alpes
Conditions:
Undernutrition
Eligibility:
All Genders
65+ years
Phase:
NA
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03867006
Start Date
February 8 2019
End Date
October 31 2022
Last Update
April 18 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
EHPAD Cité des Aînés
Saint-Etienne, France
2
EHPAD La Cerisaie
Saint-Etienne, France
3
EHPAD Le Soleil
Saint-Etienne, France