Healthy Japanese
Conditions
Interventions
Duration: 16 weeks Active food group {5-Aminolevulinic acid (ALA) phosphate A mg}
Duration: 16 weeks Placebo food group (5-ALA phosphate 0 mg)
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose HbA1c is 5.6% or more and less than 6.5% at screening before intervention
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 medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to test products 7. Individuals whose daily alcohol intake exceeds 60 g Example of 20 g pure alcohol; 500 mL: beer or canned chu-hi (5% alcohol by volume), 180 mL: sake or wine (15% alcohol by volume), 110 mL: shochu (25% alcohol by volume), 60 mL: whiskey (40% alcohol by volume) 8. Individuals who are shift workers, such as working a late-night shift or others 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. 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 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HbA1c (National Glycohemoglobin Standardization Program) at 16 weeks after intervention (16w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glucose (GLU), insulin (IRI), and body mass index (BMI) at 16w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed