Overdose safety test

UMIN ID: UMIN000055527

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/09/19
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Daily intake of the test food for 4 weeks

Outcome(s)

• Primary Outcome: Expression rate of side effects
• Secondary Outcome: [1] Expression rate of adverse events [2] Results of physical examination, clinical examination (blood test, urinalysis)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: [1] Subjects who are on treatment for a serious illness. [2] Subjects who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction. [3] Subjects with food allergies or those who may be allergic to the test food. [4] Subjects who regularly use licensed drugs or quasi-drugs that may affect the study and who are unable to discontinue their intake during the study period. [5] Subjects who regularly use health foods that may affect the study and who are unable to discontinue their intake during the study period. [6] Subjects who have had blood drawn or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test. [7] Subjects who may be unable to maintain their daily lifestyle. [8] Subjects who are pregnant or breastfeeding or planning to become pregnant during the study period. [9] Subjects who participated in other clinical trials within 3 months prior to the date of consent, or plan to participate in other clinical trials during the study period. [10] Subjects who are judged as ineligible for the study by the investigator.

Related Information

• Primary Sponsor: APO PLUS STATION CO., LTD.
• Source(s) of Monetary Support: NISSIN YORK CO., LTD.