NCT07211321

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

September 17, 2025

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Through study completion, an average of 1 year

Study Arms (1)

sarcopenia group and control group

Other: No Intervention: Observational Cohort

Interventions

No Intervention

sarcopenia group and control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Permanent residents of the community aged 60 years or older.
  • Continuous residence duration in the community for more than 5 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou university

Lanzhou, Gansu, 730000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Faecal and whole blood samples

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Jianhua Ma Doctor of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 7, 2025

Study Start

April 16, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations