UMIN ID: UMIN000054060
Registered date:10/04/2024
A human clinical study for the effects of consumption of the test food on blood metabolites in healthy Japanese
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy subjects |
| Date of first enrollment | 2024/04/11 |
| Target sample size | 15 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Single ingestion of the test food *Blood drawn before and after ingestion |
Outcome(s)
| Primary Outcome | Items related to cysteine metabolites in blood |
|---|---|
| Secondary Outcome | Questionnaire, blood test (peripheral blood test, vitamin D) |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 70years-old |
| 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, and 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, bronchial asthma, chronic fatigue syndrome, 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/or the test product related products, in particular yeast allergies 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. 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 another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician |
Related Information
| Primary Sponsor | ORTHOMEDICO Inc. |
|---|---|
| Secondary Sponsor | Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Kyoto University |
| Source(s) of Monetary Support | Mitsubishi Corporation Life Sciences Limited |
| 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 |