Healthy adults
Conditions
Interventions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese males and females ages 60 and over 2. Subjects who are able to collect and send specimens by the specified method during the specified period 3. Subjects whose defecation frequency is more than three times per week 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. suffering from serious liver, kidney, heart, respiratory, endocrine, metabolic, or immunodeficiency diseases 2. who take medication for diabetes 3. with a history or current history of drug or alcohol dependence 4. who consistently consumes more than the appropriate amount of alcohol (approximately 40 g of pure alcohol per day) 5. with extremely irregular eating habits 6. with recurring constipation or diarrhea 7. who cannot comply with restrictions on foods and supplements that affect the intestinal environment during the research period 8. who have taken antibiotics or antibacterial agents within 1 month before taking test foods. 9. who have a history of serious gastrointestinal disease surgeries 10. who have some allergies to the components of the test food products 11. who smoke 12. who have oral problems that involve bleeding, or plan to undergo dental or oral treatment 13. who are diagnosed with dry mouth 14. who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past three months from the date of consent, or who plan to participate in others 15. who are determined to be inappropriate as research subjects by the principal investigator--
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiome Oral microbiome Fecal concentration of organic acids Fecal concentration of putrefaction products Fecal concentration of ammonia Salivary stress markers OSA sleep inventory MA version Questionnaires on skin Skindex-16 POMS2 (Short Form) Fecal amount, days of defecation, frequency of defecation, BSS, fecal color, fecal odor, feeling after defecation | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed