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| Name | Class |
|---|---|
| Société des Produits Nestlé (SPN) | INDUSTRY |
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This study evaluates the effect of whey protein enriched enteral nutrition in addition to exercise training on the preservation of muscle function in critically ill patients.
One half of patients receive whey protein enriched enteral nutrition with a protein intake of 1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein intake of 1 g/kg/day.
Muscle wasting has an enormous impact on long-term physical performance and quality of life of intensive care survivors. Limitation of muscle wasting might therefore improve physical performance and quality of life. Data on high protein nutritional intake in addition to a standardized exercise training program to prevent skeletal muscle wasting during critical illness are lacking.
Objective: to determine whether early high protein intake, using an enteral whey protein supplement, in addition to a standardized exercise training program and standard enteral nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo muscle function and mass, clinical outcomes and quality of life in critically ill patients. Secondly, to determine whether high protein intake, in addition to standardized exercise and standard enteral nutrition, increases muscle protein synthesis and attenuates activation of the Ubiquitin-Proteasome pathway in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training |
|
| control group | No Intervention | standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein supplement | Dietary Supplement | Whey protein supplement to target protein intake of 1.5 g/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| in vitro loss of skeletal muscle function | measured by contractility of of individual muscle fibers | day 1-3 and day 8-10 |
| Measure | Description | Time Frame |
|---|---|---|
| loss of muscle function | Medical research council (MRC) sum score, | day 1-3, day 8-10, day 28 |
| changes in body composition | Bioelectrical impedance analysis (BIA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra N Stapel, MD | Contact | s.stapel@vumc.nl | ||
| Monique Waard | Contact | mc.dewaard@vumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sandra N Stapel, MD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| day 1-3, day 8-10, day 28 |
| loss of muscle mass | Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires | day 1-3, day 8-10, day 28 |
| quality of life | Short form (SF)- 36 questionnaire | 3 months |