None listed
Conditions
Interventions
Daily intake of control food for 7 days. Washout period (7days or more). Daily intake of test food for 7days.
Daily intake of test food for 7 days. Washout period (7 days or more). Daily intake of
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Japanese males from 20 to 39 years of age when consented. (2) Subjects with no abnormal test results in screening test. (3) Subjects with 7 to 9 times of defecation per week. (4) Subjects with regular mealtimes throughout the day. (5) Subjects available for every designated hospital admission. (6) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases. (2) Subjects with a surgical history of digestive system (except appendicectomy). (3) Subjects currently under treatment with chronic diseases. (4) Subjects who regularly take intestinal drugs or health foods which may influence intestinal regulation (including Food for Specified Health Uses and Foods with Function Claims). (5) Subjects who work on midnight and irregular shifts. (6) Subjects who cannot take preset meals to be delivered during the intake periods of test or placebo food, or who cannot comply with the requirement not to eat food other than the presets meals. (7) Subjects who cannot stop smoking and drinking alcohol during the intake periods of test or placebo food. (8) Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average amount of mineral excreted daily into feces | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation including subjective symptoms, examination by a physician in charge, hematology test, biochemical exam of blood serum chemistry, and urinary test. | — |
Countries
Japan
Contacts
Public ContactRyota Wakimoto
Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Outcome results
None listed