NCT07658612

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 10, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Genetic polymorphismsSarcopeniaCommunity-dwelling elderlyChewing abilitySwallowing functionGenotype analysis

Outcome Measures

Primary Outcomes (1)

  • Based on the results of empirical research on sarcopenia in Asian countries, a diagnostic consensus was established.

    * 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

Study Arms (2)

Case group

Possible sarcopenia

Other: Non interventional study

Control group

Non-possible sarcopenia

Other: Non interventional study

Interventions

NON

Case groupControl group

Eligibility Criteria

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

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 22, 2026

Study Start

November 14, 2025

Primary Completion

June 4, 2026

Study Completion

June 4, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations