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

Sengkang General Hospital

Status: Completed

Conditions: Frailty; Sarcopenia

Treatments: Dietary Supplement: Ensure Plus Advance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05344313

2022/2027

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Sarcopenic patients

Experimental group

Description:

Ensure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery

Treatment:

Dietary Supplement: Ensure Plus Advance

Healthy individuals

No Intervention group

Description:

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.