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Effects of test food intake on bowel movements and intestinal environment in healthy subjects

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000052450
Lead Sponsor
M&I Science CORP.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
44
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Bowel diary
Secondary Outcome Measures
NameTimeMethod
Stool test,POMS2,Food frequency questionnaire
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