Long-Term Safety Confirmation Trial of a Test Food Product

UMIN ID: UMIN000055535

Registered date:18/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Male/female adults
• Date of first enrollment: 2024/09/18
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Consumption of the test food (1 capsule a day) for 12 weeks

Outcome(s)

• Primary Outcome: Adverse events and side effects Changes in clinical laboratory values

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those that may affect sleep, stress, or gut health) three or more times per week and cannot stop consuming them from the time of consent acquisition. 2. Subjects who are taking medications that may affect sleep, stress, or gut health and cannot restrict their use from the time of consent acquisition. 3. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 4. Subjects with excessive alcohol intake. 5. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 6. Females who are pregnant or lactating, and females who could become pregnant during trial period. 7. Subjects with allergies to medications and/or food. 8. Subjects who donated blood or component (200 mL) within the last 1 months. 9. Subjects who donated his blood (400 mL) within the last 3 months. 10. Subjects who donated her blood (400 mL) within the last 4 months. 11. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study. 12. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study. 13. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: MEGMILK SNOW BRAND Co.,Ltd