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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000032641
• Date of registration: 18/05/2018
• Prospective Registration: Yes
• Primary sponsor: ORTHOMEDICO Inc.
• Public title: A verification study of safety evaluation of the test food long-term administration in humans: a randomized, double-blind, placebo-controlled, parallel study
• Scientific title: 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
• Date of first enrolment: 2018/05/19
• Target sample size: 30
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037220
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Naoko SUZUKI
• Affiliation: ORTHOMEDICO Inc. R&D Department

• Name: Kazuo YAMAMOTO
• Affiliation: ORTHOMEDICO Inc. CEO

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Healthy Japanese subjects

Intervention(s)

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 taken within the day. If you forget to take the capsules, take it as soon as you remember within the day.
Duration: 12 weeks Test material: Placebo capsules Dose: 2 capsules per day Administration: Take one capsule with water after breakfast and another capsule after dinner * Daily dose must be taken within the day. If you forget to take the capsules, take it as soon as you remember within the day.

Primary Outcome(s)

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

Source(s) of Monetary Support

THERAVALUES CORPORATION

Secondary Sponsor(s)

Medical Corporation Seishinkai, Takara Clinic

Ethics review

Status: YES
Approval date:
Contact: