Oral and Eating Health Study

UMIN ID: UMIN000054336

Registered date:08/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: oral hypofunction
• Date of first enrollment: 2024/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Participants consume one or two pieces of sausage (Schauessen (NH Foods Ltd.)) per day, daily for 3 months.

Outcome(s)

• Primary Outcome: Amount of change in indices related to oral function (number of corresponding items in the assessment of oral frailty or oral hypofunction) following 3 months of continuous consumption of sausage (Schauessen (NH Foods Ltd.)).

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: (1) Persons who are allergic to any of the foods used in the study. (2) Persons who are currently participating in another study, within 4 weeks of the completion of the study, or are scheduled to participate in the next study. (3) Persons who consume at least one rough sausage a day for at least 5 days a week. (4) Persons who are unable to measure body composition by the impedance method due to a pacemaker, artificial arm, artificial leg, etc. (5) Persons who do not take meals orally. (6) Persons who are on a restricted diet as instructed by a doctor. (7) Any other person who is deemed inappropriate as a participant by the principal investigator.

Related Information

• Primary Sponsor: Hokkaido University
• Secondary Sponsor: Research & Development Center, NH Foods Ltd.
• Source(s) of Monetary Support: NH Foods Ltd.