ObesityNCT06363253
Pilot Study of the Human Metagenome in Metabolic Diseases
An observational study of Obesity and Sarcopenia, run by Sengkang General Hospital at 1 site in Singapore.
Trial summary
This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenia, Sarcopenic Obesity
- What is being tested?
- No specific intervention
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Aug 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese and sarcopenic patients will be recruited from patients from Sengkang General Hospital, opportunistically found during their management to be sarcopenic. Obese patients will be recruited from patients who are seen in the Sengkang General Hospital Weight Management Clinic. Controls are recruited from patients who are on follow-up for other non-related conditions found opportunistically to fit the inclusion criteria, as well as healthy volunteers.
Who may be able to join
- Obese (BMI>27.5kg/m2)
- Sarcopenic patients, defined as 1) low handgrip strength (<26 for males; <18kg for females), AND/OR low gait speed (<0.8m/s) AND low muscle mass (<7.0kg/m2 for males; <5.7kg/m2 for females)
- Healthy subjects without sarcopenia, and not obese (BMI<27.5kg/m2)
Who cannot join
- No informed consent
- Presence of intestinal stoma, hence inability to collect fecal samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, 544886
Koy Min Chue, 69305000, chue.koy.min@singhealth.com.sg
About this study
Official title: Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study
This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.
Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.
We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine.
Read the detailed description
The human metagenome comprises all nucleotide sequences isolated from all organisms living on and within an individual and has been shown to have significant alterations in relation to certain diseased states related to chronic inflammation, such as obesity and sarcopenia.
The gut bacteriome, and more recently the virome, has been shown to be significantly correlated with the obese phenotype, while gut microbiome dysbiosis is known to occur in individuals with sarcopenia. Clinically, there is an unmet clinical need to better personalize the treatment of patients with metabolic disorders such as obesity and metabolic syndrome, and patients suffering from sarcopenia and frailty as a result of aging. However, the literature regarding the metagenomic signatures associated with these disorders, in particular the non-bacteriome species, bacterial metabolites, and their relationship with host metabolism, were scarce.
Thus we hypothesize, that the human metagenome and metabolome, may play a role in influencing chronic inflammatory disorders related to metabolic disorders, such as obesity and diseases related to aging like sarcopenia and aging.
This is a cohort study, involving metagenomic sequencing and metabolomic analysis, of patients metagenome and metabolome, in various diseased states. A cohort of healthy control patients without obesity or sarcopenia will also be recruited.
Samples collected will include fecal, salivary, serum, urine, mucosal samples for metagenomic sequencing and metabolomic testing.
- Being tested
- No specific intervention
- Keywords
- Obesity, Sarcopenia, Metabolic syndrome, Metagenomics, Metabolomics
- Medical subject headings
- Obesity, Sarcopenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionOther
Patient will undergo their routine clinical treatment for their related clinical condition (eg. anti-obesity or bariatric intervention for obese group; muscle strengthening interventions or necessary treatment for their concomitant medical condition for the sarcopenia group).
Follow-up testing will include repeat assessment of the subjects metagenome and metabolome over time, and after intervention
Control subjects will have no interventions performed as well.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Patients with BMI > 27.5 kg/m2 Receives: Other: No specific intervention | |
| Sarcopenic | Patients who are sarcopenic, defined by the Asian Working Group on Sarcopenia 2014 criteria, which is defined as
1. having low handgrip strength (<26kg for males; <18kg for females) AND/OR
2. Low gait speed (<0.8m/s) AND
3. Low muscle mass (<7.0kg/m2 for males; <5.7kg/m2 for females) Receives: Other: No specific intervention | |
| Controls | Healthy volunteers who are not obese (BMI <27.5kg/m2), OR who are screened and found to not be sarcopenic Receives: Other: No specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic alterations
Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time
Measured: Period of 1 year
Metabolomic alterations
Changes in serum and urinary charged metabolites and small molecules over time
Measured: Period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start14 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Nanyang Technological University, Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, Chue Koy Min, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363253
- Sponsor's protocol ID
- CIRB Ref: 2023/2073
- Status last verified
- May 2025
- First submitted
- 9 Apr 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at the moment. Deidentified data can potentially be shared following institutional review board and hospital permission.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study
- ClinicalTrials.gov ID
- NCT06363253
- Acronym / sponsor ID
- CIRB Ref: 2023/2073
- Keywords
- Obesity, Sarcopenia, Metabolic syndrome, Metagenomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Nanyang Technological University, Duke-NUS Graduate Medical School
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Apr 2024 (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.
This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.
Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.
We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine.
Detailed description
The human metagenome comprises all nucleotide sequences isolated from all organisms living on and within an individual and has been shown to have significant alterations in relation to certain diseased states related to chronic inflammation, such as obesity and sarcopenia.
The gut bacteriome, and more recently the virome, has been shown to be significantly correlated with the obese phenotype, while gut microbiome dysbiosis is known to occur in individuals with sarcopenia. Clinically, there is an unmet clinical need to better personalize the treatment of patients with metabolic disorders such as obesity and metabolic syndrome, and patients suffering from sarcopenia and frailty as a result of aging. However, the literature regarding the metagenomic signatures associated with these disorders, in particular the non-bacteriome species, bacterial metabolites, and their relationship with host metabolism, were scarce.
Thus we hypothesize, that the human metagenome and metabolome, may play a role in influencing chronic inflammatory disorders related to metabolic disorders, such as obesity and diseases related to aging like sarcopenia and aging.
This is a cohort study, involving metagenomic sequencing and metabolomic analysis, of patients metagenome and metabolome, in various diseased states. A cohort of healthy control patients without obesity or sarcopenia will also be recruited.
Samples collected will include fecal, salivary, serum, urine, mucosal samples for metagenomic sequencing and metabolomic testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: No specific interventionPatients with BMI > 27.5 kg/m2 |
| Sarcopenic | – | Other: No specific interventionPatients who are sarcopenic, defined by the Asian Working Group on Sarcopenia 2014 criteria, which is defined as 1. having low handgrip strength (<26kg for males; <18kg for females) AND/OR 2. Low gait speed (<0.8m/s) AND 3. Low muscle mass (<7.0kg/m2 for males; <5.7kg/m2 for females) |
| Controls | – | Other: No specific interventionHealthy volunteers who are not obese (BMI <27.5kg/m2), OR who are screened and found to not be sarcopenic |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese and sarcopenic patients will be recruited from patients from Sengkang General Hospital, opportunistically found during their management to be sarcopenic. Obese patients will be recruited from patients who are seen in the Sengkang General Hospital Weight Management Clinic. Controls are recruited from patients who are on follow-up for other non-related conditions found opportunistically to fit the inclusion criteria, as well as healthy volunteers.
Key inclusion criteria (3 listed)
- Obese (BMI>27.5kg/m2)
- Sarcopenic patients, defined as 1) low handgrip strength (<26 for males; <18kg for females), AND/OR low gait speed (<0.8m/s) AND low muscle mass (<7.0kg/m2 for males; <5.7kg/m2 for females)
- Healthy subjects without sarcopenia, and not obese (BMI<27.5kg/m2)
Key exclusion criteria (2 listed)
- No informed consent
- Presence of intestinal stoma, hence inability to collect fecal samples
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 |
|---|---|---|
| No specific interventionPatient will undergo their routine clinical treatment for their related clinical condition (eg. anti-obesity or bariatric intervention for obese group; muscle strengthening interventions or necessary treatment for their concomitant medical condition for the sarcopenia group). Follow-up testing will include repeat assessment of the subjects metagenome and metabolome over time, and after intervention Control subjects will have no interventions performed as well. | Other | Controls, Obese, Sarcopenic |
Primary outcome
Metagenomic alterations
Time frame: Period of 1 year
Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time
Metabolomic alterations
Time frame: Period of 1 year
Changes in serum and urinary charged metabolites and small molecules over time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided. Undecided at the moment. Deidentified data can potentially be shared following institutional review board and hospital permission.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sarcopenia, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koy Min Chue (69305000, chue.koy.min@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomic alterations (time frame: Period of 1 year). The study lists 2 primary outcomes in all. 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 15 May 2025.