Healthy Japanese subjects
Conditions
Interventions
Duration: single dose Test food: active food 1, active food 2, and placebo food Administration: Eat test food with water during meal <
[1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner. [2] Washout peri
[1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2:
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult men or menopause women for 1 or more year 2. Subjects who defecate every morning at their home 3. Subjects who can eat the prescribed diet for breakfast, lunch, and dinner 4. Subjects who have a regular bowel movement once a day in the morning 5. Subjects who can send their stool and urine after collecting stool in the morning 6. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, kidney stone, cerebrovascular disorder, rheumatism, diabetes mellitus, hypercalcemia, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who regularly take calcium-rich foods such as calcium-fortified milk 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who have physical labor in perspiration 7. Subjects who work late-night shift and the lifestyles are irregular 8. Subjects who cannot control their room temperature including not having any air conditioners and heaters 9. Subjects who have a tendency toward constipation or diarrhea 10. Subjects who have excessive fitness habit 11. Subjects who have a drinking habit 12. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 13. Subjects who are an allergic reaction to medications and/or the test food related products 14. Subjects who are pregnant, breast-feeding, or planning to become pregnant 15. 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 16. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minerals in the blood, urine, and stool *1 Assessed sodium, calcium, magnesium, and iron in minerals *2 Collected blood samples at baseline, 30 min, 60 min, 90 min, and 120 min *3 Collected urine at baseline, 2, 4, 6, 8, and 24 hours after intake *4 Collected stool at 24 hours after intake | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed