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

Sponsor

Sengkang General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05344313

Collaborator

Abbott (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Frailty	Dietary Supplement: Ensure Plus Advance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

interventional cohort studyinterventional cohort study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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