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Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients? (HMB-ICU-CH)

Primary Purpose

Critical Illness, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HMB (beta-hydroxy beta-methylbutyrate)
Sponsored by
Mette M Berger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Body composition, muscle mass, protein metabolism, enteral nutrition, ICU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Lausanne Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HMB (beta-hydroxy beta-methylbutyrate)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2018
Last Updated
August 20, 2020
Sponsor
Mette M Berger
Collaborators
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT03628365
Brief Title
Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?
Acronym
HMB-ICU-CH
Official Title
Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mette M Berger
Collaborators
Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Muscle Weakness
Keywords
Body composition, muscle mass, protein metabolism, enteral nutrition, ICU

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, double blind, controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMB (beta-hydroxy beta-methylbutyrate)
Arm Type
Active Comparator
Arm Description
HMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
Intervention Type
Dietary Supplement
Intervention Name(s)
HMB (beta-hydroxy beta-methylbutyrate)
Intervention Description
1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)
Primary Outcome Measure Information:
Title
Muscle mass of the thigh
Description
Ultrasound cross sectional area of the thigh, to quantify muscle loss
Time Frame
Change between Day 4 and Day 15
Secondary Outcome Measure Information:
Title
Body composition
Description
Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle
Time Frame
Change between Day 4 and Day 15
Title
Protein synthesis and breakdown
Description
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))
Time Frame
Change between Day 4 and Day 15
Title
Muscle strength (global and handgrip)
Description
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
Time Frame
Measurements on Days 4, 15, and 30
Title
Global Health and Mobility
Description
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
Time Frame
on days 30 and 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Lausanne Hospitals
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26797412
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.
Results Reference
result
PubMed Identifier
23514626
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.
Results Reference
result
PubMed Identifier
29406417
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.
Results Reference
result
PubMed Identifier
34358832
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.
Results Reference
derived
PubMed Identifier
33946038
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.
Results Reference
derived

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

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