A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study

A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study - A verification study of safety evaluation of the test food long-term administration in humans

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032641

Enrollment

Registered

2018-05-18

Start date

2018-05-19

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 subjects

Interventions

Duration: 12 weeks Test material: Active capsules Dose: 2 capsules per day Administration: Take one capsule with water after breakfast and another capsule after dinner * Daily dose should be take

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, urinary bladder failure, or any other chronic diseases 3. Subjects who suffered or have been suffered from diseases related to the biliary tract 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements, particularly taking anticoagulants such as warfarin 6. Subjects who eat natto more than 3 times per week 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. Physical examination 2. Urinalysis 3. Blood test 4. Subjective symptoms (the Likert scale) * Assess these tests at screening and examination before consumption and at 4, 8, and 12 weeks after consumption	—

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