UMIN ID: UMIN000055570
Registered date:20/09/2024
A verification study to evaluate the safety of excessive consumption of the test food
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Healthy Japanese |
Date of first enrollment | 2024/09/20 |
Target sample size | 10 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Duration: Four weeks Test food: Active food |
Outcome(s)
Primary Outcome | 1. Individuals who experienced adverse events |
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Secondary Outcome | 1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption) |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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) and supplements 6. Individuals who are allergic to medicines and foods related to the test product 7. Individuals who plan to have surgery, tooth extraction, or other medical treatment during the study or within 2 weeks after the end of consumption 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician |
Related Information
Primary Sponsor | ORTHOMEDICO Inc. |
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Secondary Sponsor | Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic |
Source(s) of Monetary Support | NOF CORPORATION |
Secondary ID(s) |
Contact
public contact | |
Name | Naoko Suzuki |
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan Japan 112-0002 |
Telephone | 03-3818-0610 |
nao@orthomedico.jp | |
Affiliation | ORTHOMEDICO Inc. R&D Department |
scientific contact | |
Name | Tsuyoshi Takara |
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan Japan |
Telephone | 03-5793-3623 |
t-takara@takara-clinic.com | |
Affiliation | Medical Corporation Seishinkai, Takara Clinic Director |