SarcopeniaHEROSNCT05344313
Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients
A study testing Ensure Plus Advance in people with Sarcopenia and Frailty, run by Sengkang General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty
- What is being tested?
- Ensure Plus Advance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
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.
Read more
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
- Being tested
- Ensure Plus Advance
- Keywords
- Nutrition, Prehabilitation, Surgery, Rehabilitation, Exercise, HMB
- Medical subject headings
- Sarcopenia, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Plus AdvanceDietary supplement
Also called Resistance training+2 months of rehabilitation
as in the arm description of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic patients | Experimental | Ensure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day before surgery
Secondary outcomes (5)
Change of handgrip strength after the prehabilitation programme
Change of handgrip strength after the prehabilitation programme
Measured: 1 day before surgery
Change of gait speed after the prehabilitation programme
Change of gait speed after the prehabilitation programme
Measured: 1 day before surgery
change in average length of hospitalization
change in average length of hospitalization
Measured: up to 30 days post surgery
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
Measured: 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
Measured: 1,2 and 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- interventional cohort study
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Koh Hong Xiang Frederick, Sengkang General Hospital
- Investigators
- Frederick H Koh, FRCSEd, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344313
- Sponsor's protocol ID
- 2022/2027
- Acronym
- HEROS
- Status last verified
- Oct 2024
- First submitted
- 3 Apr 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prevailing PDPA and HBRA regulations does not allow for open sharing. However, anonymised data can be shared if specifically requested for.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT05344313
- Acronym / sponsor ID
- HEROS / 2022/2027
- Conditions
- Sarcopenia, Frailty
- Keywords
- Nutrition, Prehabilitation, Surgery, Rehabilitation, Exercise, HMB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventional cohort study
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic patients | Experimental | Dietary Supplement: Ensure Plus AdvanceEnsure Plus Advance + resistance training (Prehab) Rehabilitation 2months post surgery |
| 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Plus AdvanceAlso: Resistance training+2 months of rehabilitationas in the arm description of the intervention | Dietary supplement | Sarcopenic patients |
Primary outcome
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
Time frame: 1 day before surgery
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
5 secondary outcomes
Change of handgrip strength after the prehabilitation programme
Time frame: 1 day before surgery
Change of gait speed after the prehabilitation programme
Time frame: 1 day before surgery
change in average length of hospitalization
Time frame: up to 30 days post surgery
change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery
Time frame: 3 months post surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No. Prevailing PDPA and HBRA regulations does not allow for open sharing. However, anonymised data can be shared if specifically requested for.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick H Koh, FRCSEd principal investigator
Sengkang General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Plus Advance in people with Sarcopenia and Frailty, run by Sengkang General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery (time frame: 1 day before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.