β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial)

Kym Wittholz; Kate Fetterplace; Yasmine Ali Abdelhamid; Jeffrey J Presneill; Lisa Beach; Benjamin Thomson; David Read; René Koopman; Adam M Deane

doi:10.1186/s40814-022-00990-9

β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial)

Pilot Feasibility Stud. 2022 Jan 31;8(1):21. doi: 10.1186/s40814-022-00990-9.

Authors

Kym Wittholz^{1

2}, Kate Fetterplace^{3

4}, Yasmine Ali Abdelhamid^{4

5}, Jeffrey J Presneill^{4

5}, Lisa Beach³, Benjamin Thomson⁶, David Read⁶, René Koopman^{4

7}, Adam M Deane^{4

5}

Affiliations

¹ Department of Allied Health, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, VIC, 3050, Australia. [email protected].
² Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia. [email protected].
³ Department of Allied Health, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, VIC, 3050, Australia.
⁴ Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.
⁵ Department of Intensive Care, The Royal Melbourne Hospital, Melbourne, Australia.
⁶ Department of Trauma and General Surgery, The Royal Melbourne Hospital, Melbourne, Australia.
⁷ Centre for Muscle Research, Department of Anatomy and Physiology, The University of Melbourne, Melbourne, Australia.

Abstract

Background: There are no therapies proven to diminish the muscle wasting that occurs in patients after major trauma who are admitted to the intensive care unit (ICU). β-Hydroxy-β-methylbutyrate (HMB) is a nutrition intervention that may attenuate muscle loss and, thereby, improve recovery. The primary aim of this study is to determine the feasibility of a blinded randomised clinical trial of HMB supplementation to patients after major trauma who are admitted to the ICU. Secondary aims are to establish estimates for the impact of HMB when compared to placebo on muscle mass and nutrition-related patient outcomes.

Methods: This prospective, single-centre, blinded, randomised, placebo-controlled, parallel-group, feasibility trial with allocation concealment will recruit 50 participants over 18 months. After informed consent, participants will be randomised [1:1] to receive either the intervention (three grams of HMB dissolved in either 150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed) or placebo (150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed). The intervention will be commenced in ICU, continued after ICU discharge and ceased at hospital discharge or day 28 post randomisation, whichever occurs first. The primary outcome is the feasibility of administering the intervention. Secondary outcomes include change in muscle thickness using ultrasound and other nutritional and patient-centred outcomes.

Discussion: This study aims to determine the feasibility of administering HMB to critically ill multi-trauma patients throughout ICU admission until hospital discharge. Results will inform design of a larger randomised clinical trial.

Trial registration: The protocol is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ANZCTR: 12620001305910 . UTN: U1111-1259-5534.

Keywords: Amino acids; Critical illness; Enteral nutrition; Muscle mass; Nutrition therapy; Trauma; β-Hydroxy-β-methylbutyrate.