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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with prolonged length of mechanical ventilation, prolonged intensive care (ICU) and hospital stay, increased ICU and hospital mortality, and prolonged impairment in physical function and quality of life. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days.
The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with poor outcome, and limitations of functional recovery. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days. The study is testing a nutrition complement (HMB) that is included in feeding products registered for medical nutrition by Swiss Federal Authorities, but who do not provide sufficient protein quantities.
On days 4 and 15 after ICU admission, specific investigations will include: Ultrasound measurement of the muscle quadriceps femoris (CSA), bioimpedance analysis (BIA) of body composition, protein synthesis and catabolism using amino acid tracers. On D30 and D60: telephone contact to assess global health and mobility (SF-12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMB (beta-hydroxy beta-methylbutyrate) | Active Comparator | HMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission |
|
| Placebo | Placebo Comparator | Maltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMB (beta-hydroxy beta-methylbutyrate) | Dietary Supplement | 1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass of the thigh | Ultrasound cross sectional area of the thigh, to quantify muscle loss | Change between Day 4 and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle | Change between Day 4 and Day 15 |
| Protein synthesis and breakdown | Multiple Amino acid tracer study: to detect chnges in protein metabolism between study start on day 4 and day 14 (i.e. after 10 days of intervention (HMB or placebo)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne Hospitals | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26797412 | Result | Deutz NE, Matheson EM, Matarese LE, Luo M, Baggs GE, Nelson JL, Hegazi RA, Tappenden KA, Ziegler TR; NOURISH Study Group. Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial. Clin Nutr. 2016 Feb;35(1):18-26. doi: 10.1016/j.clnu.2015.12.010. Epub 2016 Jan 18. | |
| 23514626 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| C004961 | beta-hydroxyisovaleric acid |
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Randomised, double blind, controlled trial
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Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy
| Change between Day 4 and Day 15 |
| Muscle strength (global and handgrip) | Medical Research Council muscle score (MRC) to assess upper and lower limb strength, and handgrip strength (not always feasible in ICU patients) and determine magnitude of strength loss | Measurements on Days 4, 15, and 30 |
| Global Health and Mobility | Short Form 12 (SF-12) questionnaire to assess global health and mobility: range 12 to 56 points, the upper limit reflecting return to normal activity | on days 30 and 60 |
| Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4. |
| 29406417 | Result | Engelen MPKJ, Deutz NEP. Is beta-hydroxy beta-methylbutyrate an effective anabolic agent to improve outcome in older diseased populations? Curr Opin Clin Nutr Metab Care. 2018 May;21(3):207-213. doi: 10.1097/MCO.0000000000000459. |
| 42202485 | Derived | Berger MM, Viana MV, Engelen MPKJ, Deutz NEP. Does beta-hydroxy-beta-methylbutyrate (HMB) have an anti-inflammatory impact in critically ill patients? A secondary post hoc analysis of an RCT. Clin Nutr. 2026 Jul;62:106690. doi: 10.1016/j.clnu.2026.106690. Epub 2026 May 16. |
| 40784156 | Derived | Berger MM, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Perez C, Thaden JJ, Engelen MPKJ, Deutz NEP. Cytokine response to critical illness and its relation to amino acid metabolism. Clin Nutr. 2025 Sep;52:195-202. doi: 10.1016/j.clnu.2025.07.018. Epub 2025 Jul 26. |
| 36717057 | Derived | Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Females have a different metabolic response to critical illness, measured by comprehensive amino acid flux analysis. Metabolism. 2023 May;142:155400. doi: 10.1016/j.metabol.2023.155400. Epub 2023 Jan 27. |
| 36657898 | Derived | Pantet O, Viana MV, Engelen MPKJ, Deutz NEP, Gran S, Berger MM. Impact of ss-hydroxy-ss-methylbutyrate (HMB) in critically ill patients on the endocrine axis - A post-hoc cohort study of the HMB-ICU trial. Clin Nutr ESPEN. 2023 Feb;53:1-6. doi: 10.1016/j.clnesp.2022.11.017. Epub 2022 Nov 25. |
| 34358832 | Derived | Viana MV, Becce F, Pantet O, Schmidt S, Bagnoud G, Thaden JJ, Ten Have GAM, Engelen MPKJ, Voidey A, Deutz NEP, Berger MM. Impact of beta-hydroxy-beta-methylbutyrate (HMB) on muscle loss and protein metabolism in critically ill patients: A RCT. Clin Nutr. 2021 Aug;40(8):4878-4887. doi: 10.1016/j.clnu.2021.07.018. Epub 2021 Jul 22. |
| 33946038 | Derived | Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Comprehensive metabolic amino acid flux analysis in critically ill patients. Clin Nutr. 2021 May;40(5):2876-2897. doi: 10.1016/j.clnu.2021.03.015. Epub 2021 Mar 18. |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |