Research on the Possible Relationship Between Sarcopenia and Oral Muscle Function (GSOM)

A Study on the Correlation Between the Genetic Polymorphisms of Elderly Individuals in the Community and Possible Sarcopenia and Oral Muscle Function

This study will focus on community-dwelling elderly individuals and will follow the community screening process recommended by AWGS.

It is expected to recruit 100 individuals who may have sarcopenia and 300 healthy or sub-healthy elderly individuals who are not likely to have sarcopenia, totaling 400 participants.Basic data such as age and body composition will be collected, as well as dietary records (three days), nutritional status assessments (Mini Nutritional Assessment, MNA), and oral health status records (including records of missing teeth, the number of opposing teeth, and whether participants wear fixed or removable dentures).

Chewing and swallowing abilities will be recorded using the Eating Assessment Tool (EAT-10). In a non-invasive manner, saliva samples will be collected for genomic DNA (gDNA) extraction, followed by quantitative gDNA typing analysis of seven gene loci (shown in Table 3).

Genotype data will be statistically analyzed along with participants' basic information, relevant sarcopenia screening data, and parameters related to oral health and swallowing function. This study adopts a case-control experimental design with the following objectives:

  1. to explore the incidence of possible sarcopenia in community-dwelling elderly.
  2. to investigate the relationship between oral function and possible sarcopenia in community-dwelling elderly using tongue pressure measurements.
  3. to understand the correlation between sarcopenia risk in community-dwelling elderly and seven specific genes.
  4. to examine the relationship between oral function and seven specific genes in community-dwelling elderly.
  5. to investigate the relationship between tongue pressure measurements and the values measured using edible chewing gum.
  6. to establish a standard test for evaluating oral chewing function using edible chewing gum.

By examining the possible mechanisms of the different genes involved in the causes of sarcopenia, we aim to find prevention strategies that are suitable for participants with different gene types.

Study Overview

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taoyuan, Taiwan
        • Chang Gung University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The research locations are the multimedia classroom on the 5th floor of the Department of Health and Nutrition at Chang Gung University, as well as community care centers in various districts of Taoyuan City and New Taipei City.

Description

Case group - Inclusion Criteria:

  • aged 60 years (inclusive) or older
  • general public or residing in an institution for 3 months (inclusive) or more
  • willing to participate in the experimental design and sign the consent form
  • able to eat independently by mouth
  • identified by researchers as possibly having sarcopenia

Control group-Inclusion Criteria:

  • aged 60 years (inclusive) or older
  • general public or residing in an institution for 3 months (inclusive) or more ●willing to participate in the experimental design and sign the consent form
  • able to eat independently by mouth
  • identified by researchers as not possibly having sarcopenia

Case group 、Control group- Exclusion Criteria:

  • having comorbidities, critical illnesses, undergoing major surgeries, cancer, renal failure, liver failure, kidney diseases, liver diseases, having malignant tumors in the past five years, inflammation symptoms (C-reactive protein >10mg/dl)
  • severely malnourished individuals (GNRI < 82)
  • long-term tube-fed individuals.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Possible sarcopenia
NON
Control group
Non-possible sarcopenia
NON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Based on the results of empirical research on sarcopenia in Asian countries, a diagnostic consensus was established.
Time Frame: baseline
  • The cut-off point for abnormal grip strength is less than 28 kg for men and less than 18 kg for women
  • 6-meter walking speed less than 1.0 second/meter
  • 5-time chair stand test greater than or equal to 12 seconds
  • Short physical performance battery, SPPB greater than or equal to 9 points The above data will be combined to determine whether sarcopenia is possible
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2025

Primary Completion (Actual)

June 4, 2026

Study Completion (Actual)

June 4, 2026

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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