Skip to main content
OpenTrials
Completed

NCT Number: NCT05344313

Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients

Aims:

Clinical frailty severely impacts the physical, functional and physiological reserves necessary for the recovery after surgery. Sarcopenia, a multifactorial, multi-organ process which lead to loss of muscle mass over time, eventually resulting in clinical frailty. These 2 entities result in an increased morbidity and mortality from surgery. They also lead to a slower recovery from surgery with some patients never reaching baseline function after their surgery. It is, therefore, important to optimize patients with sarcopenia prior to surgery to reduce the incidence of morbidity and mortality.

Nutrition and resistance training have been shown to be able to curb the effects of sarcopenia. However, the type and regime of nutrition is still unknown.

Hypotheses:

The study team hypothesize that Ensure Plus Advance + HMB (beta-hydoxy-beta-methylbutyrate) would reduce the amount of IMAT (inter and intramuscular adipose tissue) in sarocpaenic patients after 2-4 weeks of prehabilitation. This effect would be sustained even after surgery and would continue to improve up to 3-months post-surgery whilst participating in rehabilitation. Taking Ensure Plus Advance + HMB would also improve functional parameters after prehabilitation, ensure a similar QoL 1-month post-surgery even if biochemical parameters may not show a significant improvement.

Methods:

The investigators would be conducting a pilot interventional cohort with an institution with an established prehabilitation programme (SKH) to evaluate the effect of the use a high protein, high calorie oral nutritional supplement (ONS) with HMB on muscle quality, using a device with Automated Intelligence (AI), in sarcopenic patients undergoing gastrointestinal surgery. Primary outcomes will be changes in Intermuscular Adipose Tissue (IMAT) while secondary outcomes include changes in functional parameters, quality-of-life (QoL), surgical outcomes and biochemical results.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sengkang General Hospital

Singapore, 544886

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between 40-90 years old
  • are sarcopenia (defined by the Asian Workgroup of Sarcopenia 2019 definition)
  • due to undergo elective major gastrointestinal surgery
  • able to satisfy at least 2 weeks of prehabilitation before surgery
  • ambulant
  • able to comply with physiotherapy and dietician advice

Exclusion criteria

  • Are pregnant
  • Are prisoners
  • Intellectually, mentally or emotionally deemed not able to provide an informed consent and/or are unable to fill up the post-procedure questionnaires
  • Have disease conditions requiring emergent/semi-emergent operation
  • Diabetes on oral hyperglycemic agents (OHGA)
  • Chronic Kidney Disease (CKD) or End-stage Renal Failure (ESRF)
  • Unable to or decline assessment for sarcopenia

Treatment and study plan

Ensure Plus Advance

Dietary Supplement

as in the arm description of the intervention

Other names: Resistance training+2 months of rehabilitation

Primary outcomes

  1. change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery

    Time frame: 1 day before surgery

    change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery

Secondary outcomes

  1. Change of handgrip strength after the prehabilitation programme

    Time frame: 1 day before surgery

    Change of handgrip strength after the prehabilitation programme

  2. Change of gait speed after the prehabilitation programme

    Time frame: 1 day before surgery

    Change of gait speed after the prehabilitation programme

  3. change in average length of hospitalization

    Time frame: up to 30 days post surgery

    change in average length of hospitalization

  4. change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery

    Time frame: 3 months post surgery

    change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery

  5. change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery

    Time frame: 1,2 and 3 months post surgery

    change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery

Sponsors and collaborators

Lead sponsor

Sengkang General Hospital

Other

Collaborators

  • Abbott

Registry information

Official study title

Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study

Acronym: HEROS

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 25, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.