Healthy Adult
Conditions
Interventions
Daily ingestion 180 g of test food (low dose) for 4 weeks.
Daily ingestion 180 g of test food (high dose) for 4 weeks.
Daily ingestion 180 g of placebo food for 4 weeks.
Sponsors
Hokkaido Information University
National Agriculture and Food Research Organization
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 aware of having a tendency toward constipation. 3. Subjects with defecation frequency less than 5 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 such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 3. Subjects who may cause some skin troubles by measuring electroencephalogram and/or heart rate variability. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects who take digoxin. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods especially based on wheat, milk, and egg. 11. Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements and/or gut microbiota. 12. Subjects who regularly take staple food with high dietary fiber. 13. Subjects who regularly take yoghurt, lactic acid bacteria beverage, and natto. 14. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 15. Subjects who have used antibiotics within 12 weeks prior to the current study. 16. 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 weeks, prior to the current study. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. 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 |
|---|---|
| Defecation frequency and gut microbiota at 4 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel diary, Heart rate variability, VAS questionnaire on stress, electroencephalogram during sleeping, sleeping record | — |
Countries
Japan
Contacts
Public ContactJun NISHIHIRA
Hokkaido Information University Health Information Science Center
Outcome results
None listed