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NCT Number: NCT06363253

Pilot Study of the Human Metagenome in Metabolic Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(obese cohort):

  • Obese (BMI>27.5kg/m2)

Inclusion criteria

(sarcopenic cohort):

  • 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)

Inclusion criteria

(control cohort):

  • Healthy subjects without sarcopenia, and not obese (BMI<27.5kg/m2)

Exclusion criteria

  • No informed consent
  • Presence of intestinal stoma, hence inability to collect fecal samples

Treatment and study plan

No specific intervention

Other

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.

Primary outcomes

  1. Metagenomic alterations

    Time frame: Period of 1 year

    Metagenomic alterations in the DNA/ RNA sequences of the saliva, stool (+/- mucosal) metagenome over time

  2. Metabolomic alterations

    Time frame: Period of 1 year

    Changes in serum and urinary charged metabolites and small molecules over time

Study contacts

Contact information is provided by the study sponsor or research team.

Koy Min Chue

CONTACT

[email protected]

69305000

Sponsors and collaborators

Lead sponsor

Sengkang General Hospital

Other

Collaborators

  • Duke-NUS Graduate Medical School
  • Nanyang Technological University
  • Singapore General Hospital

Registry information

Official study title

Understanding the Role of the Human Metagenome in Obesity, Metabolic Diseases, Chronic Inflammation, Sarcopenia and Sarcopenic Obesity - a Pilot Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 12, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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