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Safety overdose study of test food

Safety overdose study of test food: Open-label study - Safety overdose study of test food: Open-label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059174
Enrollment
17
Registered
2025-09-24
Start date
2025-09-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 20 to 64 (2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Subjects with a history of serious disease such as mental disorder, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (2) Subjects who have undergone gastrointestinal surgery(3) Subjects with abnormal liver and renal function test values (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular eating habits s (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (12) Subjects who drink more than 60 g of pure alcohol per day (13) Subjects who smoke more than 21 cigarettes per day on average (14) Subjects who are participating in or will participate in other clinical trials at the start of this study (15) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

MeasureTime frame
Adverse event Physical examination (blood pressure, pulse) Laboratory test values (Hematology, blood biochemistry, urinalysis)

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026