Clinical trial NCT05344313: Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients
Official title: Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frailty
Keywords: Nutrition
Prehabilitation
Surgery
Rehabilitation
Exercise
HMB
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional cohort study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
timeFrame: 1 day before surgery
Secondary outcomes:
measure: Change of handgrip strength after the prehabilitation programme
timeFrame: 1 day before surgery
measure: Change of gait speed after the prehabilitation programme
timeFrame: 1 day before surgery
measure: change in average length of hospitalization
timeFrame: up to 30 days post surgery
measure: change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery
timeFrame: 3 months post surgery
measure: change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery
timeFrame: 1,2 and 3 months post surgery
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
affiliation: Sengkang General Hospital
name: Frederick H Koh, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References: