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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: a randomized, placebo-controlled, double-blind, parallel-group comparison 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-UMIN000061980
Enrollment
20
Registered
2026-06-19
Start date
2026-06-19
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Healthy Japanese

Interventions

Duration: 4 weeks Test product: Food 1 Duration: 4 weeks Test product: Food 2

Sponsors

ICHIMARU PHARCOS Co., Ltd.
Lead Sponsor

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 receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 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 consume 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 regularly consume tsubo grass 7. Individuals who are allergic to medications or foods related to the test product 8. Individuals who are pregnant, lactating, or planning pregnancy during this study 9. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
1. Individuals who experienced adverse events

Secondary

MeasureTime frame
1. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening 2. Physical measurements, urine test, peripheral blood test

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: Sep 19, 2026