Healthy Japanese subjects
Conditions
Interventions
Daily intake of test food for 2 weeks ->
Washout for 3 weeks ->
Daily intake of placebo food for 2 weeks
Daily intake of placebo food for 2 weeks ->
Daily intake of test food for 2 weeks
Sponsors
Fujicco Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for participation in the screening: 1) Healthy adults aged 20 years or older 2) Subjects with a bowel movement frequency of at least twice per week 3) Subjects who are receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being to personally sign a written informed consent Selection criteria in the screening: 1) Subjects who endogenously possess gut microbial metabolite X will be selected for participation in the subsequent intervention study
Exclusion criteria
Exclusion criteria: 1) Subjects with severe cardiovascular, respiratory, gastrointestinal, urinary, endocrine, or hematological disease 2) Subjects with hypothyroidism 3) Subjects who, at the time of informed consent, are receiving treatment at a medical institution for the treatment or prevention of disease, including hormone therapy, pharmacotherapy, exercise therapy, or diet therapy, or who are judged to be in a condition requiring such treatment 4) Subjects with food or drug allergies 5) Subjects who habitually consume foods for specified health uses, foods with functional claims, supplements, or health foods rich in dietary fiber for the purpose of regulating bowel function or improving the intestinal environment 6) Subjects who consume excessive amounts of alcohol (average weekly alcohol intake exceeding 60 g/day [Reference Materials for Health Japan 21 (the Second Term)]) 7) Subjects who are pregnant, breastfeeding, or intending to become pregnant during the study period 8) Subjects who are participating in another clinical study, including a clinical trial 9) Subjects who are judged by the principal investigator to be unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbial metabolite X | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbial metabolites other than X Gut microbiota Defecation status Water content in feces pH value in feces | — |
Countries
Japan
Contacts
Public ContactMasamichi Watanabe
Fujicco Co., Ltd. R&D Department
Outcome results
None listed