Healthy adults
Conditions
Interventions
Sponsors
KSO Corporation
KSO Corporation, Watanabe Hospital, Higashinaebo Hospital, Kanamori Giken Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males and females from 20 to 65 years old. 2) Subjects who are able to collect and send the required amount of fecal samples within the designated period (with stable bowel movements) 3) Subjects who reside in the Tokyo metropolitan area or the Sapporo area during the study period 4) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: Subjects 1) who have a severe liver, kidney, heart, respiratory, endocrine, or metabolic disorders, or immunodeficiency. 2) who are taking medication for diabetes. 3) who suffer from a disease requiring urgent treatment or who have serious complications. 4) who have a history of or current drug or alcohol dependence. 5) who have recurrent gastrointestinal symptoms such as constipation or diarrhea. 6) who regularly consume alcohol (consuming more than 40 g/day of alcohol). 7) who are smokers. 8) who have extremely irregular eating habits. 9) who are unable to discontinue the intake of Foods for Specified Health Uses (FOSHU), foods with functional claims, nutritional supplements, or dietary supplements during the study period. 10) who have allergies to any food components contained in the study food. 11) who have taken antibiotics within one month before the start of intake. 12) who are pregnant, intend to become pregnant during the study period, or are breastfeeding. 13) who are currently participating in, or intend to participate in, other clinical studies involving foods, drugs, cosmetics, or pharmaceuticals. 14) deemed ineligible by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| organic acids concentration in feces | — |
Secondary
| Measure | Time frame |
|---|---|
| gut microbiota, stool volume, number of defecation days, defecation episodes, BSS, stool color, stool odor, feeling after defecation, Subjective questionnaire | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed