SarcopeniaNCT07334210
The Characteristics of Gut Microbiota in Patients With Sarcopenia and the Development of Probiotics
An observational study of Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The primary aim of this study is to identify the composition and characteristics of the gut microbiota in patients with sarcopenia in older adults, and compare these with the gut microbiota characteristics of older adults and young control groups to determine differences. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2025to 31 Dec 2025
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary general hospital
Who may be able to join
- Sarcopenia patient group
- Individuals aged 65 to 90 years
- Meet the diagnostic criteria for sarcopenia based on the 2019 Asian Working Group for Sarcopenia (AWGS) guidelines:
- Low appendicular skeletal muscle mass
- DEXA: <7.0 kg/m² (men), <5.4 kg/m² (women)
- BIA: <7.0 kg/m² (men), <5.7 kg/m² (women)
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- Low muscle strength
- Handgrip strength: <28 kg (men), <18 kg (women) or
- Low physical performance
- 6-meter walk speed <1.0 m/s
- 5-chair stand test ≥12 seconds
- Short Physical Performance Battery (SPPB) score ≤9
- Voluntarily agree to participate in the clinical study and sign the informed consent form
- Older adult control group
- Individuals aged 65 to 90 years
- Voluntarily agree to participate in the clinical study and sign the informed consent form
- Young adult control group
- Individuals aged 20 to 50 years
- Voluntarily agree to participate in the clinical study and sign the informed consent form
Who cannot join
- Individuals currently under treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal/urinary, neurological, psychiatric systems, infectious diseases, or malignant tumors (Exception: skin tumors other than melanoma are excluded; cancer survivors may participate if more than 5 years have passed since complete remission).
- Individuals who have difficulty performing independent activities of daily living due to musculoskeletal or neurological diseases, or cognitive impairment (e.g., those with spinal disorders requiring surgery or having walking limitations).
- Individuals who regularly consume alcohol according to WHO daily intake standards (≥ 40 g/day for men, ≥ 20 g/day for women).
- Heavy smokers (≥ 20 cigarettes/day).
- Individuals with AST (GOT) or ALT (GPT) levels ≥ 3 times the upper limit of normal established by the testing institution.
- Patients with uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, measured after the subject has rested for 10 minutes).
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- Patients with uncontrolled diabetes mellitus (HbA1c > 7.0%).
- Individuals with TSH ≤ 0.1 μIU/mL or ≥ 10 μIU/mL.
- Individuals deemed unsuitable for other reasons at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bo-Ram Kim contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
The primary aim of this study is to identify the composition and characteristics of the gut microbiota in patients with sarcopenia in older adults, and compare these with the gut microbiota characteristics of older adults and young control groups to determine differences. Secondary purpose of this study is to provide data on the characteristics of gut microbiota for the development of probiotics effective in treating sarcopenia in older adults.
Read the detailed description
Sarcopenia is a condition characterized by the loss of skeletal muscle mass and decline in physical function associated with aging. It is closely related to chronic diseases and geriatric disease and it is known to increase the risk of frailty, disability, falls, fractures, and mortality. The microbiome is closely associated with a wide range of human diseases, including metabolic disorders, cancer, infectious diseases, and immune-related conditions, and is considered one of the most valuable biomarkers for disease prevention and diagnosis. This indicates growing global interest and research activity on the connection between sarcopenia and gut microbiota. Through this study, we expect to elucidate the relationship between age-related sarcopenia and gut microbiota, which may provide important clues for the diagnosis and treatment of this condition.
- Conditions
- Sarcopenia
- Keywords
- Gut microbiota, Sarcopenia, Older adults
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Sarcopenia patient group | Individuals aged 65 to 90 years. Meet the diagnostic criteria for sarcopenia based on the 2019 Asian Working Group for Sarcopenia (AWGS) guidelines: * Low appendicular skeletal muscle mass * DEXA: <7.0 kg/m² (men), <5.4 kg/m² (women) * BIA: <7.0 kg/m² (men), <5.7 kg/m² (women) * Low muscle strength * Handgrip strength: <28 kg (men), <18 kg (women) or * Low physical performance * 6-meter walk speed <1.0 m/s * 5-chair stand test ≥12 seconds * Short Physical Performance Battery (SPPB) score ≤9 | |
| 2. Older adult control group | Individuals aged 65 to 90 years | |
| 3. Young adult control group | Individuals aged 20 to 50 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity analysis values
Alpha diversity analysis values (Rarefaction and Boxplot) of gut microbiota in each group
Measured: Baseline (visit 1)
Short Physical Performance Battery (SPPB)
Short Physical Performance Battery (SPPB) results for sarcopenia physical performance evaluation in each group
Measured: Screening(Visit 0)
Secondary outcomes (7)
Beta diversity analysis values
Beta diversity analysis values of gut microbiota (PCoA plot)
Measured: Baseline(Visit 1)
Taxa plot
Taxa plot (Relative abundance) analysis values
Measured: Baseline(Visit 1)
Handgrip strength
Handgrip strength
Measured: Screening(Visit 0)
6-meter walking speed
6-meter walking speed
Measured: Screening(Visit 0)
appendicular skeletal muscle mass
appendicular skeletal muscle mass
Measured: Screening(Visit 0)
lower limb muscle strength
lower limb muscle strength
Measured: Baseline (Visit 1)
Timed Up & Go test
Timed Up \& Go test
Measured: Baseline (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start13 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
- Investigators
- Jae-Young Lim, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334210
- Sponsor's protocol ID
- B-2502-953-301
- Status last verified
- Nov 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Gut Microbiota in Patients With Sarcopenia and the Development of Probiotics
- ClinicalTrials.gov ID
- NCT07334210
- Acronym / sponsor ID
- B-2502-953-301
- Conditions
- Sarcopenia
- Keywords
- Gut microbiota, Sarcopenia, Older adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jan 2026 (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.
The primary aim of this study is to identify the composition and characteristics of the gut microbiota in patients with sarcopenia in older adults, and compare these with the gut microbiota characteristics of older adults and young control groups to determine differences. Secondary purpose of this study is to provide data on the characteristics of gut microbiota for the development of probiotics effective in treating sarcopenia in older adults.
Detailed description
Sarcopenia is a condition characterized by the loss of skeletal muscle mass and decline in physical function associated with aging. It is closely related to chronic diseases and geriatric disease and it is known to increase the risk of frailty, disability, falls, fractures, and mortality. The microbiome is closely associated with a wide range of human diseases, including metabolic disorders, cancer, infectious diseases, and immune-related conditions, and is considered one of the most valuable biomarkers for disease prevention and diagnosis. This indicates growing global interest and research activity on the connection between sarcopenia and gut microbiota. Through this study, we expect to elucidate the relationship between age-related sarcopenia and gut microbiota, which may provide important clues for the diagnosis and treatment of this condition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Sarcopenia patient group | – | –Individuals aged 65 to 90 years. Meet the diagnostic criteria for sarcopenia based on the 2019 Asian Working Group for Sarcopenia (AWGS) guidelines: * Low appendicular skeletal muscle mass * DEXA: <7.0 kg/m² (men), <5.4 kg/m² (women) * BIA: <7.0 kg/m² (men), <5.7 kg/m² (women) * Low muscle strength * Handgrip strength: <28 kg (men), <18 kg (women) or * Low physical performance * 6-meter walk speed <1.0 m/s * 5-chair stand test ≥12 seconds * Short Physical Performance Battery (SPPB) score ≤9 |
| 2. Older adult control group | – | –Individuals aged 65 to 90 years |
| 3. Young adult control group | – | –Individuals aged 20 to 50 years |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary general hospital
Key inclusion criteria (19 listed)
- Sarcopenia patient group
- Older adult control group
- Young adult control group
Key exclusion criteria (9 listed)
- Individuals currently under treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal/urinary, neurological, psychiatric systems, infectious diseases, or malignant tumors (Exception: skin tumors other than melanoma are excluded; cancer survivors may participate if more than 5 years have passed since complete remission).
- Individuals who have difficulty performing independent activities of daily living due to musculoskeletal or neurological diseases, or cognitive impairment (e.g., those with spinal disorders requiring surgery or having walking limitations).
- Individuals who regularly consume alcohol according to WHO daily intake standards (≥ 40 g/day for men, ≥ 20 g/day for women).
- Heavy smokers (≥ 20 cigarettes/day).
- Individuals with AST (GOT) or ALT (GPT) levels ≥ 3 times the upper limit of normal established by the testing institution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alpha diversity analysis values
Time frame: Baseline (visit 1)
Alpha diversity analysis values (Rarefaction and Boxplot) of gut microbiota in each group
Short Physical Performance Battery (SPPB)
Time frame: Screening(Visit 0)
Short Physical Performance Battery (SPPB) results for sarcopenia physical performance evaluation in each group
7 secondary outcomes
Beta diversity analysis values
Time frame: Baseline(Visit 1)
Taxa plot
Time frame: Baseline(Visit 1)
Handgrip strength
Time frame: Screening(Visit 0)
6-meter walking speed
Time frame: Screening(Visit 0)
appendicular skeletal muscle mass
Time frame: Screening(Visit 0)
lower limb muscle strength
Time frame: Baseline (Visit 1)
Timed Up & Go test
Time frame: Baseline (Visit 1)
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 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Bo-Ram Kim contact
Jae-Young Lim principal investigator
Seoul National University Bundang Hospital
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 Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 19 inclusion and 9 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 12 Jan 2026. 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 South Korea. 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 Jae-Young Lim (• +821053900373, drlim1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity analysis values (time frame: Baseline (visit 1)). 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 12 Jan 2026.