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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia, Frailty

Intervention / Treatment
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* Dietary Supplement: Ensure Plus Advance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: interventional cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarcopenic patients<br>Ensure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery | Dietary Supplement: Ensure Plus Advance<br>* as in the arm description of the intervention<br>* Other names: Resistance training+2 months of rehabilitation;|
| No Intervention: Healthy individuals<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Prehabilitation, Surgery, Rehabilitation, Exercise, HMB