Healthy Adult
Conditions
Interventions
Daily ingestion 90 g of test food for 4 weeks.
Daily ingestion 90 g of placebo food for 4 weeks.
Sponsors
Hokkaido Information 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 who are feeling stress. 3. Subjects with defecation frequency less than 6 times per week.
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 may cause some skin troubles by measuring heart rate variability. 4. Subjects who take digoxin. 5. Subjects who have used antibiotics within 12 wks prior to this study. 6. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 7. Subjects with ACP. 8. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 9. Subjects with major surgical history relevant to the digestive system. 10. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 11. Subjects with severe anemia. 12. Pre- or post-menopausal women complaining of obvious physical changes. 13. Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, milk, and egg. 14. Subjects who regularly take drugs and/or functional foods which affect bowel movements, gut microbiota, stress and/or sleep. 15. Subjects who regularly take staple food with high dietary fiber. 16. Subjects who regularly take yoghurt, lactic acid bacteria beverage, and/or natto. 17. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 18. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this 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 wks prior to this study. 21. Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS questionnaire on stress at 4 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel diary, gut microbiota, fatty acids in feces, IgA in feces, BDNF in blood, cortisol in saliva, heart rate variability, sleeping record, survey on subjects' sleeping and mental and physical conditions, VAS questionnaire. | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed