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

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Sarcopenia
• Intervention / Treatment: Dietary supplement: Ensure Plus Advance

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 544886
    • Sengkang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarcopenic patients; Ensure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery	Dietary supplement: Ensure Plus Advance; as in the arm description of the intervention; Other Names: Resistance training+2 months of rehabilitation
No Intervention: Healthy individuals; To make meaningful comparison of muscle quality, 10 healthy non-sarcopenic individuals from the same age range would also be recruited and will undergo muscle quality assessment using MuscleSound® once upon recruitment so that an objective comparison for IMAT can be made with our sarcopenic study cohort. This is to aid the study team to identify "normal" IMAT vs an IMAT for sarcopenic individuals. Any improvement of our cohort's muscle quality can be benchmarked against healthy muscle quality so that more meaningful comparison can be made. This control group would not be undergoing surgery, nor will they have any ONS supplied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery	change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery	1 day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of handgrip strength after the prehabilitation programme	Change of handgrip strength after the prehabilitation programme	1 day before surgery
Change of gait speed after the prehabilitation programme	Change of gait speed after the prehabilitation programme	1 day before surgery
change in average length of hospitalization	change in average length of hospitalization	up to 30 days post surgery
change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery	change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery	3 months post surgery
change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery	change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery	1,2 and 3 months post surgery

Collaborators and Investigators

• Sponsor: Sengkang General Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Frederick H Koh, FRCSEd, Sengkang General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Surgery; Nutrition; Prehabilitation; HMB
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 2022/2027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Prevailing PDPA and HBRA regulations does not allow for open sharing. However, anonymised data can be shared if specifically requested for.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No