NCT05344313: HEROS

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

Completed NA Last updated 23 October 2024

What this trial tests

NA trial testing Ensure Plus Advance in Sarcopenia in 47 participants. Completed in 30 June 2024.

Timeline

1 June 2022

Primary endpoint
31 December 2023

30 June 2024

Quick facts

Lead sponsor	Sengkang General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	1 June 2022
Primary completion	31 December 2023
Estimated completion	30 June 2024
Sites	1 location across Singapore

Drugs / interventions tested

• Ensure Plus Advance

Conditions studied

• Sarcopenia — all drugs for Sarcopenia →
• Frailty — all drugs for Frailty →

Sponsor

Sengkang General Hospital

Who can join

Adults 40 to 90, any sex, with Sarcopenia or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Branched chain amino acids in hepatic encephalopathy and sarcopenia in liver cirrhosis: Evidence and uncertainties.
   Marrone G, Serra A, Miele L, Biolato M, et al · · 2023 · cited 16× · PMID 37274800 · DOI 10.3748/wjg.v29.i19.2905
2. Evaluating the Impact of Multimodal Prehabilitation with High Protein Oral Nutritional Supplementation (HP ONS) with Beta-Hydroxy Beta-Methylbutyrate (HMB) on Sarcopenic Surgical Patients-Interim Analysis of the HEROS Study.
   Koh FH, Yik V, Chin SE, Kok SS, et al · · 2024 · cited 4× · PMID 39770973 · DOI 10.3390/nu16244351
3. Long-Term Outcomes of Multimodal Prehabilitation with High Protein Oral and HMB Supplementation in Sarcopenic Surgical Patients: The HEROS Study
   Shua I, Tan Y, Yik V, Hong J, et al · · 2026