NCT03628365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

August 7, 2018

Last Update Submit

August 20, 2020

Conditions

Critical IllnessMuscle Weakness

Keywords

Body compositionmuscle massprotein metabolismenteral nutritionICU

Outcome Measures

Primary Outcomes (1)

  • Muscle mass of the thigh

    Ultrasound cross sectional area of the thigh, to quantify muscle loss

    Change between Day 4 and Day 15

Secondary Outcomes (4)

  • Body composition

    Change between Day 4 and Day 15

  • Protein synthesis and breakdown

    Change between Day 4 and Day 15

  • Muscle strength (global and handgrip)

    Measurements on Days 4, 15, and 30

  • Global Health and Mobility

    on days 30 and 60

Study Arms (2)

HMB (beta-hydroxy beta-methylbutyrate)

ACTIVE COMPARATOR

HMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission

Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)

Placebo

PLACEBO COMPARATOR

Maltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission

Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)

Interventions

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)

HMB (beta-hydroxy beta-methylbutyrate)Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

Location

Related Publications (8)

  • 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.

    PMID: 26797412RESULT

  • 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.

    PMID: 23514626RESULT

  • 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.

    PMID: 29406417RESULT

  • 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.

    PMID: 40784156DERIVED

  • 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.

    PMID: 36717057DERIVED

  • 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.

    PMID: 36657898DERIVED

  • 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.

    PMID: 34358832DERIVED

  • 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.

    PMID: 33946038DERIVED

MeSH Terms

Conditions

Critical IllnessMuscle Weakness

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised, double blind, controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 14, 2018

Study Start

September 17, 2018

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

CH(1)