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

NCT05344313 | Completed DMC

• 1 other identifier: 2022/2027
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty

Keywords

Nutrition; Prehabilitation; Surgery; Rehabilitation; Exercise; HMB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of handgrip strength after the prehabilitation programme

  1 day before surgery

• Change of gait speed after the prehabilitation programme

  1 day before surgery

• 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

  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

Study Arms (2)

Sarcopenic patients

EXPERIMENTAL

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

Dietary Supplement: Ensure Plus Advance

Healthy individuals

NO INTERVENTION

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.

Interventions

Ensure Plus Advance DIETARY_SUPPLEMENT

as in the arm description of the intervention

Also known as: Resistance training+2 months of rehabilitation

Sarcopenic patients

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sengkang General Hospital: lead
• Abbott: collaborator

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

Location

MeSH Terms

Conditions

Sarcopenia; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Behavior

Study Officials

• Frederick H Koh, FRCSEd

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant Colorectal Surgeon

Model Details: interventional cohort study

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)