JPRN-UMIN000053189
Not yet recruiting
未知
Improvement of the intestinal environment through food intake and its effect on sleep - Improvement of intestinal environment, sleep study
Clinical Creative Co., Ltd.0 sites27 target enrollmentStarted: January 8, 2024Last updated:
Conditionshealthy person
Overview
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Clinical Creative Co., Ltd.
- Enrollment
- 27
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to 60years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Those who have taken, or will take during the study period, any medication (e.g., antiallergic drugs, sleep inducing drugs, sleep aids, etc.) that may affect the study one month prior to the start of intake of the test food. 2\. Those who regularly consume food for specified health use, functional foods, supplements, or health foods that may affect the study at least 3 times a week, and those who are unable to limit their intake during the study period. 3\. Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc. 4\. Persons suspected of having a chronic or acute serious infectious disease. 5\. Those who are scheduled to be vaccinated during the study period. 6\. Pregnant or planning to become pregnant, and those who are breastfeeding. 7\. Those who habitually drink alcohol more than 3 times a week and more than 1 sake equivalent (beer: 1 medium bottle, whiskey: 1 double, shochu: 0\.6 gou). 8\. Those who have an extremely irregular diet. 9\. Have a BMI of 30 or higher 10\. Those who plan to change their lifestyle drastically during the study period. 11\. Persons who are primarily responsible for the care of nursing caregivers or infants, or whose sleep may be disturbed by other external factors (e.g., roommates or pets). 12\. Persons who are allergic to food 13\. Who are currently participating in a clinical study of another drug or health food, and who plan to participate in another clinical study within one month after the completion of the study, or after consent to participate in the study. 14\. Those who are not engaged in a full\-time occupation. 15\. Those who work shift work or late\-night work, have irregular sleeping or waking times, or sleep extremely short or irregular hours. 16\. Do not have a smartphone. 17\. Those who cannot install the Fitbit application on their smartphones. 18\. Any other person who is deemed by the principal investigator to be inappropriate to participate in this study.
Investigators
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