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

A study to evaluate the safety of excessive consumption of the test food: an open-label study - A 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-UMIN000060469
Enrollment
10
Registered
2026-01-26
Start date
2026-01-26
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: Four weeks Test product: Food containing lipopolysaccharide (LPS) derived from Pantoea agglomerans Administration: Consume 10 capsules per day after the first meal of the day, either by al

Sponsors

Macrophi Inc.
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 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 medicines (including herbal medicines) or supplements 6. Individuals who have allergies to medicines or foods related to the test product, particularly those with a silver allergy or concerns about wheat allergy 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have participated in other clinical studies within 28 days before informed consent, 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

MeasureTime frame
1. Individuals who experienced adverse events

Secondary

MeasureTime frame
1. Individuals whose urinalysis and peripheral blood test values were within the reference range at screening but became outside the reference range after intervention 2. Physical measurements, urinalysis, and 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