NCT07658599

Brief Summary

The main purpose of this study is to screen middle-aged and elderly (≧ 45 years old) individuals at high risk of sarcopenia and sarcopenia, and to investigate whether sarcopenia can improve dental bite force and tongue pressure in middle-aged and elderly sarcopenia subjects when given edible chewing training colloidal intervention.This trial method will recruit 120 subjects for oral strength training twice a day for 8 weeks, and compare the difference in chewing level between the subjects using the oral strength training intervention and the oral strength training intervention before and after the test. The differences between dental occlusal force and tongue pressure after training were also explored. The experiment mainly evaluated the scales related to dental occlusal force, tongue pressure, and quality of life, because the quality of oral muscles is highly correlated with the diet and lifestyle of the elderly, and also affects the physical health and mobility of the elderly. Although the loss of muscle mass due to aging may be unavoidable, appropriate oral strength training intervention may delay or modify the adverse effects of sarcopenia and improve quality of life in sarcopenia subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
2.1 years 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

2 months

First QC Date

June 10, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

sarcopeniachewingoral strength trainingmuscle strength

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

    From Intervention to Experiment Completion (eight weeks)

Study Arms (1)

NON

OTHER

NON

Behavioral: oral muscle strength training

Interventions

Oral muscle strength tests are conducted the day before the intervention and during the eighth week after the intervention.

Also known as: NON
NON

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old (inclusive) or older
  • The general public or the institution has stayed for more than 3 months (inclusive)
  • Those who accept the experimental design and intervention, and are willing to sign the consent form
  • The source of the diet is that you can eat by mouth independently
  • Those who meet the diagnosis definition of sarcopenia by the Asian Sarcopenia Consensus Association
  • No history of chewing and swallowing

You may not qualify if:

  • Those who may have allergic or uncomfortable reactions to edible chewing colloids (honey flavor)
  • Feeders
  • Other dietitians who cannot complete this researcher
  • Those who cause discomfort when chewing (such as temporomandibular joint pain, oral ulcers, severe tooth decay, etc.)
  • Those who report choking and coughing when chewing

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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 22, 2026

Study Start

March 1, 2024

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations