Overdose safety test

Overdose safety test - Overdose safety test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058971

Enrollment

Registered

2025-09-03

Start date

2025-09-04

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

None listed

Interventions

Daily intake of the test food for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [1] Healthy Japanese males and females aged between 20 and 69 at the time of consent. [2] Participants who can submit the written informed consent form.

Exclusion criteria

Exclusion criteria: [1] Participants who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction. [2] Participants receiving treatment for any of the following chronic conditions: arrhythmia, liver dysfunction, renal impairment, cerebrovascular disease, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses. [3] Participants with food allergies or those who may be allergic to the test food. [4] Participants 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] Participants who regularly use health foods that may affect the study and who are unable to discontinue their intake during the study period. [6] Participants 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] Participants who may be unable to maintain their daily lifestyle. [8] Participants who are pregnant or breastfeeding or planning to become pregnant during the study period. [9] Participants who participated in other clinical trials within one month prior to the date of consent, or plan to participate in other clinical trials during the study period. [10] Participants who are judged as ineligible for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Expression rate of side effects	—

Secondary

Measure	Time frame
[1] Expression rate of adverse events [2] Results of physical examination, clinical examination (blood test, urinalysis)	—

Countries

Japan

Contacts

Public ContactMasako Mizuuchi

APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.

food-contact@apoplus.co.jp03-6777-7789

Outcome results