Safety Verification Trial for Test Food Consumption

UMIN ID: UMIN000052181

Registered date:12/09/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Male/female adults
• Date of first enrollment: 2023/09/13
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consumption of the test food (1 bottle a day) for 28 days
Consumption of the placebo food (1 bottle a day) for 28 days

Outcome(s)

• Primary Outcome: Incidence of some kind of adverse event and/or side effect, changes in clinical laboratory values.
• Secondary Outcome: Sleep related items

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who are consuming Food for specified health use, functional foods, or dietary supplements that affect the autonomic nervous system, metabolism, stress, fatigue, and sleep, and who cannot discontinue their use during the trial period. 2. Subjects being under some kind of continuous medical treatment, including the study period. 3. Subjects who are currently participating in other clinical trials for pharmaceuticals or dietary supplements, or plan to participate in another clinical trial within four weeks after the end of the current trial. 4. Subjects with excessive alcohol intake. 5. Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period. 6. Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. 7. Subjects who have sensitive skin and skin rash due to rrubber constriction, etc. 8. Subjects with a history or current diagnosis of severe diseases in organs like the heart, liver, kidney, or digestive system. 9. Subjects who are pregnant, nursing, or intend to become pregnant during the trial period. 10. Subjects with allergies to medications or foods. 11. Subjects who donated blood or component (200 mL) within the last 1 months. 12. Subjects who donated his blood (400 mL) within the last 3 months. 13. Subjects who donated her blood (400 mL) within the last 4 months. 14. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research. 15. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research. 16. 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: Asahi Quality & Innovations, Ltd.