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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061654
Enrollment
10
Registered
2026-05-22
Start date
2026-05-22
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: Capsule containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take 10 capsules with water without chewing per day. *If you forget to ta

Sponsors

Yotsuba Milk Products 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 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 or foods related to the test product 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. 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 values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening 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: Jul 3, 2026