search
Back to results

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

Primary Purpose

Sarcopenia, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ensure Plus Advance
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Nutrition, Prehabilitation, Surgery, Rehabilitation, Exercise, HMB

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sengkang General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sarcopenic patients

Healthy individuals

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of handgrip strength after the prehabilitation programme
Change of handgrip strength after the prehabilitation programme
Change of gait speed after the prehabilitation programme
Change of gait speed after the prehabilitation programme
change in average length of hospitalization
change in average length of hospitalization
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
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

Full Information

First Posted
April 3, 2022
Last Updated
October 23, 2022
Sponsor
Sengkang General Hospital
Collaborators
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT05344313
Brief Title
Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients
Acronym
HEROS
Official Title
Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sengkang General Hospital
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Frailty
Keywords
Nutrition, Prehabilitation, Surgery, Rehabilitation, Exercise, HMB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
interventional cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenic patients
Arm Type
Experimental
Arm Description
Ensure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery
Arm Title
Healthy individuals
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Plus Advance
Other Intervention Name(s)
Resistance training+2 months of rehabilitation
Intervention Description
as in the arm description of the intervention
Primary Outcome Measure Information:
Title
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
Description
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
Time Frame
1 day before surgery
Secondary Outcome Measure Information:
Title
Change of handgrip strength after the prehabilitation programme
Description
Change of handgrip strength after the prehabilitation programme
Time Frame
1 day before surgery
Title
Change of gait speed after the prehabilitation programme
Description
Change of gait speed after the prehabilitation programme
Time Frame
1 day before surgery
Title
change in average length of hospitalization
Description
change in average length of hospitalization
Time Frame
up to 30 days post surgery
Title
change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery
Description
change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery
Time Frame
3 months post surgery
Title
change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery
Description
change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery
Time Frame
1,2 and 3 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederick H Koh, FRCSEd
Phone
+65 69302000
Email
frederick.koh.h.x@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Khasthuri G
Phone
+65 69302000
Email
g.khasthuri@skh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick H Koh, FRCSEd
Organizational Affiliation
Sengkang General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sengkang General Hospital
City
Singapore
ZIP/Postal Code
544886
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick H Koh, FRCSEd
Phone
84281117
Ext
65
Email
frederick.koh.h.x@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Prevailing PDPA and HBRA regulations does not allow for open sharing. However, anonymised data can be shared if specifically requested for.

Learn more about this trial

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

We'll reach out to this number within 24 hrs