Healthy Adult
Conditions
Interventions
Daily ingestion 5 tablets of active test food for 4 weeks.
Daily ingestion 5 tablets of placebo test food for 4 weeks.
Sponsors
Hokkaido Information University
National Agriculture and Food Research Organization National Institute of Advanced Industrial Science and Technology Bioresource and Bioenvironment Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Subjects with ailment on defecation.
Exclusion criteria
Exclusion criteria: 1. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 2. Subjects with gastrointestinal disorders. 3. Subjects who use gastrointestinal drugs or female hormone once or more a week. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who repeat constipation and diarrhea. 10. Subjects with defecation frequency 3 or less/ 9 or more per weeks. 11. Subjects with stool characteristics (Bristol scale) 5 or more. 12. Subjects who have habit to consume yogurt 6 days or more per week. 13. Subjects who have habit to consume beverages include lactic acid bacteria and/or bifidobacteria 2 days or more per week. 14. Subjects who have habit to consume beverages include dietary fiber reinforced food and/or oligo sugar 1 day or more per week. 15. Subjects who have allergy to drugs or foods especially based on soybean and yeast. 16. Subjects who used antibiotics within 12 weeks, prior to the current study. 17. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 week, prior to the study. 19. Pregnant or lactating women or women who expect to be pregnant during this study. 20. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the study. 21. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel diary at 4 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal flora, gut metabolome, heart rate variability, sleeping record, electroencephalogram during sleeping, survey on subjects' sleeping and mental and physical conditions, blood metabolome, analysis of fecal samples, the Japanese version of constipation assessment scale MT version (CAS-MT), blood inflammatory marker. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed