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Completed

NCT Number: NCT07658599

Study on the Effect of Edible Mastication Training Colloid Intervention of Oral Muscle Training in Patients of Sarcopenia

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University of Science and Technology

Taoyuan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 45 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

Exclusion criteria

  • 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

Treatment and study plan

oral muscle strength training

Behavioral

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

Other names: NON

Primary outcomes

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

    Time frame: From Intervention to Experiment Completion (eight weeks)

    • 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

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Acronym: EMTC-Sarc

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
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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