A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements

UMIN ID: UMIN000054099

Registered date:30/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2022/08/19
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): To intake SAC-containing garlic supplements 5 tablets(10mg) / day for 4 weeks

Outcome(s)

• Primary Outcome: Hematological examination Urinalysis
• Secondary Outcome: Adverse event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (a) persons who have changed their habitats to take supplements within past 4 weeks (b) Persons who work in night shift or in day and night shift (c) persons who have been treated their illness or prevention in a clinic at their informed consent (d) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (e) persons with the medical histories of alcoholism or drug dependence (f) persons who might be developed allergic reaction to foods. (g) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (h) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (i) persons who will not be judged suitable to the participants by the investigator

Related Information

• Primary Sponsor: User Life Science Co.,Ltd.
• Source(s) of Monetary Support: Bizen Chemical Co.,Ltd.