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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2020-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Muscle Function in Nutritionally at Risk, Elderly Patients

NCT03071354

Muscle Weakness ICU-acquired Weakness

WITHDRAWN NA

Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate

NCT01150526

Healthy

COMPLETED PHASE1

Anabolic Potential of 3-hydroxybutyrate (3-OHB) and Whey Protein in a Human Catabolic Inflammatory Disease Model

NCT04064268

Endotoxemia Muscle Loss Catabolic State +2 more

COMPLETED NA

Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness.

NCT05074862

Intensive Care Unit Acquired Weakness Critical Illness

UNKNOWN PHASE2

The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

NCT02717013

Obesity

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, double blind, controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HMB (beta-hydroxy beta-methylbutyrate)

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

Group Type ACTIVE_COMPARATOR

HMB (beta-hydroxy beta-methylbutyrate)

Intervention Type DIETARY_SUPPLEMENT

1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)

Placebo

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

Group Type PLACEBO_COMPARATOR

HMB (beta-hydroxy beta-methylbutyrate)

Intervention Type DIETARY_SUPPLEMENT

1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HMB (beta-hydroxy beta-methylbutyrate)

1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No