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

Sarcopenia Clinical Trial

— HEROS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05344313
• Other study ID #: 2022/2027
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Sengkang General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Dietary Supplement:
• Ensure Plus Advance
as in the arm description of the intervention

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Sengkang General Hospital	Abbott

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of handgrip strength after the prehabilitation programme	Change of handgrip strength after the prehabilitation programme	1 day before surgery
Secondary	Change of gait speed after the prehabilitation programme	Change of gait speed after the prehabilitation programme	1 day before surgery
Secondary	change in average length of hospitalization	change in average length of hospitalization	up to 30 days post surgery
Secondary	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	3 months post surgery
Secondary	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	1,2 and 3 months post surgery