Healthy Japanese adult people
Conditions
Interventions
Duration: single dose Test material: Test food 1, Test food 2, and placebo food Administration: Take 16 capsules and one dye capsule, which make stool dye, with at least 240 mL of water after eating
[1] Day 1: Eat the prescribed diet for breakfast, lunch, and dinner. Day 2: Eat the prescribed diet for breakfast and then take Test food 1 and the dye capsule. Eat the prescribed diet for lunch and
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese male people who defecate every morning at their home 2. Subjects who can eat the prescribed diet for breakfast, lunch, and dinner 3. Subjects who can send their stools and urine samples by parcel delivery service after collected sample in the morning 4. Subjects who have a regular bowel movement once a day in the morning 5. Subjects who can collect their urine for 24 hours on the collected urine day 6. Subjects who can take 16 capsules (2.2 cm x 0.77 cm) after eating breakfast 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who are confirmed dyed stools ONCE in the next morning after eating the prescribed diet with the dye capsule at both screening 1 and 2
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, intestinal disorder or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to ribwort (Plantains) pollen, grass pollen, and melon 6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 7. Subjects who are judged as ineligible to participate in the study by the physician 8. Subjects who have physical labor such as sweats 9. Subjects who cannot control their room temperature including not have any air conditioner 10. Subjects who have a tendency toward constipation or diarrhea 11. Subjects who have a fitness habit 12. Subjects who have a drinking habit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sodium concentration in stool 2. Sodium concentration in urine * For urine evaluation, collect the urine from after eating the prescribed diet, eating test food, and the dye capsule. For stool evaluation, collect the stools in the next morning after eating the prescribed diet, eating test food, and the dye capsule. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mineral concentration in stool Concentrations of potassium, calcium, magnesium, phosphorus, copper, zinc, manganese, and iron 2. Mineral Concentration in urine Concentrations of potassium, calcium, magnesium, phosphorus, iodine, selenium, chromium, and molybdenum 3. Questionnaires about hunger and sleepiness (by the Visual Analogue Scale; VAS) 4. Stool examination stool weight, stool moisture, crude protein, crude fat, crude ash, crude fiber *1, 2, 4 Assess by using the collected stools sample in the next morning after eating the prescribed diet, eating test food, and the dye capsule. *3 Assess the questionnaires after eating the prescribed diet, eating test food, and the dye capsule. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed