Study of connection between various masticatory indices according to phagodynamometer and lifestyle disease risk factors, and of mastication intervention effects

UMIN ID: UMIN000025875

Registered date:27/01/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 1. metabolic syndrome 2. obesity 3. healthy subjects
• Date of first enrollment: 2017/02/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Mastication and dietary counseling intervention for 6 months for lifestyle disease patient.
Lifestyle disease patient(diet treatment only)
healthy volunteer(No treatment)

Outcome(s)

• Primary Outcome: Connection between mastication-related indices measured using a phagodynamometer and obesity-related factors, and the amount of change before and after dietary counseling intervention * Mastication-related indices: mastication frequency, mastication time (time to chew each piece of food), masticatory force (intensity of force when chewing)
• Secondary Outcome: 1)BMI (Body Mass Index), 2)body composition (Dexa, INBody), 3)insulin resistance index, biochemical (serum) 4)arteriosclerotic index, 5)content of experimental food (cabbage, rice ball, doughnut), 6)experimental food order (1. cabbage, 2. rice ball, 3. doughnut), 7)cognitive function (cognitive function balancer: PC assignment for examining cognitive function), 8)personality characteristics (survey form for TEG, NEO, perfectionism, self-efficacy, social support, etc.), 9)Sakata eating habit questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: [Exclusion criteria] 1)Person having a mastication disorder due to cranial neuropathy or an oral disease 2)Has an otitis disorder 3)Has a mental illness which has been determined to make participation in the study difficult 4)Has otherwise been deemed unsuitable as a research subject by an investigator

Related Information

• Primary Sponsor: Kansai Medical University Hospital Health Science
• Secondary Sponsor: None
• Source(s) of Monetary Support: None