Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test food: Fermentation product of soy milk with lactic acid bacteria
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subject who does not become ill by consumption soy milk 3. Subjects who are judged as eligible to participate in the study by the physician 4. Select 11 subjects who defecate three to five times per week (constipation group) and 11 subjects who defecate more than five times per week (normal group) 5. The number of men and women is about the same
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS), or any other chronic diseases 4. Subjects regularly taking medications (including herbal medicines) and supplements 5. Subjects allergic to medications and/or soybeans 6. Subjects who are pregnant, lactating, or intending to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 8. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of side effects 2. Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical examination 2. Urinalysis 3. Blood test | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed