SarcopeniaNCT07211321
Linking Diet, Inflammation, Gut Microbiota, and Sarcopenia: A Cross-Sectional Study
An observational study of Sarcopenia, run by Jianhua Ma at 1 site in China.
Trial summary
Based on the analysis of dietary characteristics, gut microbiota diversity, and composition, this study investigates the relationships between the dietary inflammatory potential, gut microbiota, and sarcopenia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 1,220 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2024to 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This community-based cross-sectional study enrolled permanent residents aged 60 years or older who had been living in the community for more than 5 years.
Who may be able to join
- Permanent residents of the community aged 60 years or older.
- Continuous residence duration in the community for more than 5 years.
Who cannot join
- Taking medications known to affect muscle function (e.g., corticosteroids, protein supplements, muscle enhancers).
- Requiring walking assistance or having severe cognitive impairment that would preclude successful completion of assessments including bioelectrical impedance analysis (BIA), gait speed measurement, and handgrip strength testing.
- Presence of a cardiac pacemaker, which contraindicates BIA measurement.
- Diagnosis of one or more chronic diseases that significantly limit dietary intake.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lanzhou university
Lanzhou, Gansu, 730000
Jie Li Master student, 0086 15698480898, jieli2023@lzu.edu.cn
About this study
Official title: Exploring the Relationship of Diets Inflammatory, Gut Microbiota, and Sarcopenia: A Cross-Sectional Study
Based on the analysis of dietary characteristics, gut microbiota diversity, and composition, this study investigates the relationships between the dietary inflammatory potential, gut microbiota, and sarcopenia. Furthermore, it explores the mediating role of gut microbiota in the association between the dietary inflammatory index and the risk of sarcopenia. The findings are expected to provide insights into the mechanisms through which dietary inflammation influences the development and progression of sarcopenia, and to offer a basis for dietary and nutritional interventions aimed at preventing or managing this condition.
- Conditions
- Sarcopenia
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| sarcopenia group and control group | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sarcopenia
The diagnosis of sarcopenia is confirmed according to the AWGS 2019 criteria, which requires the assessment of muscle strength, physical performance, and muscle mass.
Measured: Through study completion, an average of 1 year
Change in absolute abundance of Faecalibacterium prausnitzii
16S rRNA absolute quantification was used to detect the microbial composition of the fecal samples.
Measured: Through study completion, an average of 1 year
Dietary Characteristics
Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.
Measured: Through study completion, an average 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 posted7 Oct 2025
- Study start16 Apr 2024
- 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.
- 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
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianhua Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianhua Ma, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211321
- Sponsor's protocol ID
- IRB23070101
- Other IDs
- No. 23JRRA1064
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship of Diets Inflammatory, Gut Microbiota, and Sarcopenia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07211321
- Acronym / sponsor ID
- IRB23070101
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Jianhua MaUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Oct 2025 (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.
Based on the analysis of dietary characteristics, gut microbiota diversity, and composition, this study investigates the relationships between the dietary inflammatory potential, gut microbiota, and sarcopenia. Furthermore, it explores the mediating role of gut microbiota in the association between the dietary inflammatory index and the risk of sarcopenia. The findings are expected to provide insights into the mechanisms through which dietary inflammation influences the development and progression of sarcopenia, and to offer a basis for dietary and nutritional interventions aimed at preventing or managing this condition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sarcopenia group and control group | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This community-based cross-sectional study enrolled permanent residents aged 60 years or older who had been living in the community for more than 5 years.
Key inclusion criteria (2 listed)
- Permanent residents of the community aged 60 years or older.
- Continuous residence duration in the community for more than 5 years.
Key exclusion criteria (4 listed)
- Taking medications known to affect muscle function (e.g., corticosteroids, protein supplements, muscle enhancers).
- Requiring walking assistance or having severe cognitive impairment that would preclude successful completion of assessments including bioelectrical impedance analysis (BIA), gait speed measurement, and handgrip strength testing.
- Presence of a cardiac pacemaker, which contraindicates BIA measurement.
- Diagnosis of one or more chronic diseases that significantly limit dietary intake.
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 Intervention: Observational CohortNo Intervention | Other | sarcopenia group and control group |
Primary outcome
The prevalence of sarcopenia
Time frame: Through study completion, an average of 1 year
The diagnosis of sarcopenia is confirmed according to the AWGS 2019 criteria, which requires the assessment of muscle strength, physical performance, and muscle mass.
Change in absolute abundance of Faecalibacterium prausnitzii
Time frame: Through study completion, an average of 1 year
16S rRNA absolute quantification was used to detect the microbial composition of the fecal samples.
Dietary Characteristics
Time frame: Through study completion, an average of 1 year
Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.
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 7 Oct 2025.
- 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.
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 Jianhua Ma at 1 site in China.
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 2 inclusion and 4 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 7 Oct 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 China. 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 Jianhua Ma Doctor of Medicine (0086 18993157029, majianhua@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of sarcopenia (time frame: Through study completion, an average of 1 year). The study lists 3 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 7 Oct 2025.