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Completed

NCT Number: NCT07658612

Research on the Possible Relationship Between 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Non interventional study

Other

NON

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

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

Acronym: GSOM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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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