Healthy subjects
Conditions
Interventions
4-weeks intake of the test food A
4-weeks intake of the test food B
Sponsors
M&I Science CORP.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male and female subjects between the ages of 20 and 65 at the time of written consent. 2. Subjects who defecate 3 to 5 times per week. 3. Subjects who do not eat enough fiber in usual dietary life. 4. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who are currently receiving medication or outpatient treatment for some serious disease. 2. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician. 3. Subjects who may develop allergies to the test food. 4. Subjects who have a current or a history of drug dependence or alcohol dependence. 5. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6. Subjects who have irregular rhythm of life due to night work or shift work. 7. Subjects who are with extremely irregular eating, sleeping, or other habits. 8. Subjects who have an extremely unbalanced diet. 9. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases. 10. Subjects who have undergone digestive organ (stomach, liver, gallbladder, pancreas, colon, etc.) surgery within the past year 11. Subjects with (suspected) chronic or acute infections. 12. Subjects who use health foods,supplements, and medicines that contain ingredients that affect bowel movements and the intestinal environment. 13. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period. 14. Subjects who have donated more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 15. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period. 16. Subjects who have difficulty in complying with the recording of various questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool test,POMS2,Food frequency questionnaire | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
M&I Science CORP. Clinical Development Department
Outcome results
None listed