Clinical trial NCT03628365: Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?
Official title: Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Muscle Weakness
Keywords: Body composition
muscle mass
protein metabolism
enteral nutrition
ICU
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2018-08-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double blind, controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* likely length of stay \>5 days
* on mechanical ventilation
* likely survival \>7 days
* full treatment
* functional gastro-intestinal tract
* presence of a central venous catheter

Exclusion Criteria:

* absence of consent
* less than 18 years patients
* gastro-intestinal dysfunction
* major burns \>20% body surface
* admission for cardio-respiratory arrest or brain injury
* pregnancy or lactation
* diabetes mellitus (I and II)
* statin treatment
* patient on parenteral nutrition
* absence of central venous line
* participation in another interventional trial

Primary outcomes:
measure: Muscle mass of the thigh
timeFrame: Change between Day 4 and Day 15
Secondary outcomes:
measure: Body composition
timeFrame: Change between Day 4 and Day 15
measure: Protein synthesis and breakdown
timeFrame: Change between Day 4 and Day 15
measure: Muscle strength (global and handgrip)
timeFrame: Measurements on Days 4, 15, and 30
measure: Global Health and Mobility
timeFrame: on days 30 and 60
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.