Healthy Japanese
Conditions
Interventions
Maizinol (UP165), 2500 mg/day, 20 capsules/day for 4 weeks
Placebo (Dextrin), 20 capsules/day for 4 weeks
Sponsors
Unigen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged between 18 and 75 4. Healthy individuals 5. Individuals who are willing and able to provide informed consent and comply with all study procedures 6. Individuals who maintain a stable lifestyle, including regular meals, exercise, and sleep schedules 7. Individuals who are willing to refrain from taking any new supplements, functional foods, or medicines that may affect sleep or mood during the study period. 8. Individuals who are not allergic to corn or corn products related to the test product 9. Individuals who are able to understand and communicate in the language used in the informed consent and research materials 10. Individuals who are not currently or recently participating in other clinical trials
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 medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to corn or corn products 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 in another study during this study 9. Individuals who are shift workers 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events during the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of new abnormal values in urine tests or blood parameters relative to baseline. 2. Descriptive changes in physical measurements, urinalysis, and blood biochemistry. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed