Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing Tetragenococcus halophilus No.1 Administration: Take one tablet with water at the breakfast once a day. *If you forget to take the test food, take
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy individuals 5. Individuals whose hemoglobin level is closer to 10 g/dL among those who have 10 g/dL~12 g/dL of hemoglobin level at screening (before consumption)
Exclusion criteria
Exclusion 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, or any other chronic diseases 4. Individuals who are undergoing medical treatment for anemia 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medications (including herbal medicines) and supplements 7. Individuals who are allergic to medicines and/or the test product related products 8. Individuals who have a smoking habit 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. The measured value of hemoglobin level at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The logarithmic value of hemoglobin level at 12w 2. The measured value and logarithmic value of hemoglobin level at 6 weeks after consumption (6w) 3. The measured values and logarithmic values of the number of white blood cells, the number of red blood cells, hematocrit value, the number of platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, ferritin, and erythropoietin at 6w and 12w 4. Individuals whose responses to "vertigo," "shortness of breath or palpitation," "body lassitude," "easily tired," "coldness," "depression," "headache," "difficulty falling asleep," "loss of appetite," and "irritability" are improved by one or more levels at 6w and 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed