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Critical IllnessHMB-ICU-CHNCT03628365

Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?

A study testing HMB (beta-hydroxy beta-methylbutyrate) in people with Critical Illness and Muscle Weakness, run by Mette M Berger at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness, Muscle Weakness
What is being tested?
HMB (beta-hydroxy beta-methylbutyrate)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteSwitzerland
Study dates
17 Sep 2018to 6 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • diabetes mellitus (I and II)
  • statin treatment
  • patient on parenteral nutrition
  • absence of central venous line
  • participation in another interventional trial

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Lausanne Hospitals

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial

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.

Read the 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).

Being tested
HMB (beta-hydroxy beta-methylbutyrate)
Keywords
Body composition, muscle mass, protein metabolism, enteral nutrition, ICU
Medical subject headings
Critical Illness, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT03628365
Study groupRoleWhat they receive
HMB (beta-hydroxy beta-methylbutyrate)Active comparatorHMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
Receives: Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)
PlaceboPlacebo comparatorMaltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
Receives: Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle mass of the thigh

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

    Measured: Change between Day 4 and Day 15

Secondary outcomes (4)

  1. Body composition

    Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle

    Measured: Change between Day 4 and Day 15

  2. 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))

    Measured: Change between Day 4 and Day 15

  3. 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

    Measured: Measurements on Days 4, 15, and 30

  4. 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

    Measured: on days 30 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start17 Sep 2018
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double blind, controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628365
Sponsor's protocol ID
CER-2018-00556
Acronym
HMB-ICU-CH
Status last verified
Aug 2020
First submitted
7 Aug 2018
Last updated
21 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26797412

  • 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.

    PubMed 23514626

  • 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.

    PubMed 29406417

  • 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.

    PubMed 42202485

  • 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.

    PubMed 40784156

  • 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.

    PubMed 36717057

  • 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.

    PubMed 36657898

  • 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.

    PubMed 34358832

  • 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.

    PubMed 33946038

Questions about this trial

What is this clinical trial studying?

A study testing HMB (beta-hydroxy beta-methylbutyrate) in people with Critical Illness and Muscle Weakness, run by Mette M Berger at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle mass of the thigh (time frame: Change between Day 4 and Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03628365, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.

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