Healthy Volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subjects who voluntarily give written informed consent 2)Healthy subjects who are aged 20-59 3)Subjects who can participate in dietary interventions, fecal samplings, blood samplings and urine 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 have constipation or diarrhea for more than 3 days in one week 3) 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 4) Subjects with allergies 5) Subjects who used antibiotics within last one month prior to fecal samplings 6) Subjects who donated more than 400 mL of blood within last 12 months (male) or within last 16 months (female), who donated more than 200 mL of blood within last one month, or who donated blood components within last two weeks prior to this study 7) Subjects who underwent GI tract surgery in the past half year 8) Subjects who are participating in other clinical studies or who are planning to participate in other clinical studies 9) Subjects who work night shifts 10) Subjects who are facing big changes in situation (such as getting married or divorced, a change in residence, or a job transfer) 11) Subjects who are during lactation or pregnancy, who wish to get pregnant, or who cannot turn in fecal samples because of menstruation 12) Subjects who are judged to be ineligible for this study by lead principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -variations in gut microbial metatranscriptome -variations in blood metabolome | — |
Countries
Japan
Contacts
Otsuka Pharmaceutical Co., Ltd. Otsu Nutraceuticals Research Institute