A verification study to evaluate the safety of excessive consumption of the test food

A verification study to evaluate the safety of excessive consumption of the test food: an open-label study - A verification study to evaluate the safety of excessive consumption of the test food

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057651

Enrollment

Registered

2025-04-18

Start date

2025-04-18

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 Japanese

Interventions

Duration: Four weeks Test product: Dried bonito dashi powder Administration: Take four packets daily, dissolved in 200~400 mL of hot water, adjusting the concentration to your preference. *If you

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to seafood 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. Individuals who experienced adverse events	—

Secondary

Measure	Time frame
1. Individuals whose values of urinalysis and blood test are outside the reference range after intervention despite within the reference range at screening	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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