Healthy Volunteers
Conditions
Interventions
Group 1a Starting from placebo and switching placebo and test food every 4 weeks (48 weeks in total)
Group 1b Starting from test food and switching test food and placebo every 4 weeks (48 weeks i
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Mitsui Fudosan Co., Ltd. TechDoctor, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects who live in Kashiwanoha Smart City 2)Subjects who voluntarily give written informed consent 3)Healthy subjects who are aged 20-59 4)Subjects who can participate in dietary interventions, intake of test foods, blood samplings, urine samplings, and fecal samplings as scheduled
Exclusion criteria
Exclusion criteria: 1)Subjects whose blood test results are judged to be ineligible for this study by lead principal investigator 2)Subjects who had a history of GI disorders and cardiovascular disorders, or who had a history of treatments by doctors for more than 1 months 3)Subjects with allergies 4)Subjects who used antibiotics within last one month prior to fecal samplings 5)Subjects who underwent GI tract surgery in the past half year 6)Subjects who are participating in other clinical studies or who are planning to participate in other clinical studies 7)Subjects who are during lactation and pregnancy or who wish to get pregnant 8)Subjects who are judged to be ineligible for this study by lead principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation of activity ratio within 24 hours | — |
Countries
Japan
Contacts
Public ContactAtsushi Ueda
Otsuka Pharmaceutical Co., Ltd. Otsu Nutraceuticals Research Institute
Outcome results
None listed