Healthy male/female adults
Conditions
Interventions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy male/female subjects ranging in age from 20 to 64, at informed consent. (2) Subjects who defecate less than five times a week. (3) Subjects who can take two meal of the test food per day. (4) Subjects who can receive and keep the test foods once or twice a week. (5) Subjects who can give informed consent, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who have an experience of living with serious disease. 2. Subjects who have chronic diseases. 3. Patients with gastrointestinal diseases that affect digestion and absorption or defecation. 4. Subjects who have an experience of drug dependence or alcohol dependence. 5. Subjects who plan to take medicines that affect the intestinal environment that affect bowel movements from 1 month. 6. Subjects who habitually consume foods containing a large amount of dietary fiber. 7. Subjects who are taking antibiotics or antibacterial agents. 8. Subjects who consume health foods that may improve constipation. 9. Subjects who have reported allergies to food or medicines. 10. Subjects who consistently drink more than the appropriate amount of alcohol. 11. Subjects who smoke excessively (more than 21 cigarettes/day). 12. Subjects with a BMI of 30.0 or more. 13. Pregnant 14. Subjects who participate in research involving the intake of other foods or using drugs. 15. Subjects who plan to participate in the research with cohabitants. 16. Subjects who plan to change their lifestyle, diet, or living environment. 17. Subjects with irregular eating habits. 18. Subjects who had less than one meal per day. 19. Subjects who plan to receive vaccines during the study period. 20. Subjects who have collected more than 200 mL of blood within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent. 21. Subjects who are on a carbohydrate restriction or diet. 22. Subjects who are judged to be inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora (next generation-targeted amplicon sequencing analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation status; the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain 2. In stool; short chain fatty acids, organic acids, ammonia, spoiled products, pH and water 3. In saliva; cortisol, cortisol corrected by protein, alpha-amylase, and alpha-amylase corrected by protein 4. Constipation assessment scale mid term 5. Visual Analog Scale; stress, fatigue, the feeling at waking up this morning, concentration 6. Clinical test value | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed