Functional exploratory research of foods
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000049673
- Lead Sponsor
- Meiji Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 44
Not provided
1. Those who belongs to clinical Study group or microbiome group 2. Those who participated in other clinical trials and monitoring examinations during the month before screening, or who plan to participate in other clinical trials after this clinical trial consent 3. Those who have some type of chronic illness and are undergoing drug treatment 4. Those who previous appendectomy or lower gastrointestinal surgery in the past 5. Those who have undergone a barium stomach X-ray or a enteroscopy or a colonoscopy and used laxatives during the month prior to the screening period, or bowel cleansing, or who are scheduled to undergo such an examination during this study. 6. Those who are allergic to dairy ingredients 7. Those who aware of lactose intolerance 8. Those who have taken, ingested, or used any pharmaceutical, quasi-drug, or herbal medicine that may affect the study at least once a week during the 3 months prior to the screening, or is scheduled to take, ingest, or use such pharmaceutical, quasi-drug, or herbal medicine at least once during the study 9. Those who plan to take or use supplements or health foods that may affect the study at least once during the study 10. Those who have regularly consumed food containing the test ingredient within 1 month prior to the screening period 11. Those who regularly consume large amount of alcohol 12. Those who pregnant or those who plan or wish to become pregnant during the study 13. Those who is breastfeeding 14. Those who plan to travel abroad, travel for more than one week, or go on a business trip during the period from one week before the screening period to the end of the study 15. Those whose stool bifidobacteria counts are below the detection limit in the screening 16. Subjects judged as unsuitable for the study by the principal investigator or research physician for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gut microbiome
- Secondary Outcome Measures
Name Time Method Quality of life Questionnaire 1) Izumo Scale 2) OSA sleep inventory 3) POMS2 Japanese edition 4) The Brief Job Stress Questionnaire