Investigation of the effect of test food on the intestinal barrier
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000048679
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1. Subjects who have been reported to have galactosemia 2. Subjects who have history of gastrointestinal surgical procedures 3. Subjects who take food or supplement which have the possibility to affect the results of the present study more than 4 days a week before 2 months of informed consent 4. Subjects who can't restrict food or supplement which have the possibility to affect the results of the present study from the observation period to the present study period 5. Subjects who take medications that may affect bowel symptoms or non-steroidal anti-inflammatory drugs such as aspirin more than 3 days a week before 1 months of informed consent 6. Subjects who have taken antibiotics before 2 months of informed consent 7. Subjects who can't restrict taking OTC drugs, quasi-drugs, supplements, or health foods from the day before the examination until the completion of the examination 8. Subjects who are expected to undergo a major change in their home, work, or other living environment during the research period 9. Subjects who are smokers 10. Subjects who have abdominal symptoms by ingesting dairy products 11. Subjects with food allergies 12. Subjects who are pregnant or lactating, or intending to become pregnant during the study 13. Subjects who had participated in other clinical trials within the past month 14. Subjects suffering from or undergoing treatment for diabetes, digestive diseases, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 15. Subjects who tested positive for hepatitis B virus or hepatitis C virus in the screening 16. Subjects deemed unsuitable for the present study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal barrier index
- Secondary Outcome Measures
Name Time Method Blood/fecal tests Subjective symptoms