Research on the effects of test food intake on physical and mental health in healthy women

UMIN ID: UMIN000054159

Registered date:15/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/04/17
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake period: 4 weeks Test food: grain Intake method: Take the prescribed amount twice a day at home. It is acceptable even if there are days when the subject cannot take it due to unavoidable circumstances.
Intake period: 4 weeks Test food: grain Intake method: Take the prescribed amount twice a day at home. It is acceptable even if there are days when the subject cannot take it due to unavoidable circumstances.

Outcome(s)

• Primary Outcome: Defecation status (according to Roma IV standards) Time of evaluation: Before intake of test food and 2 weeks, 4 weeks after intake
• Secondary Outcome: pittsburgh sleep quality index:PSQI Indicators from mental health surveys Indicators from health-related QOL surveys

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 22years-old
• Gender: Female
• Exclude criteria: 1. Those with barley allergy 2. Those with wheat allergy (consider cross-reactivity) 3. Those who regularly use drugs or supplements for bowel movements, sleep, or mental health.

Related Information

• Primary Sponsor: Other
• Source(s) of Monetary Support: Other