Improvement of the intestinal environment through food intake and its effect on sleep
- Conditions
- healthy person
- Registration Number
- JPRN-UMIN000053189
- Lead Sponsor
- Clinical Creative Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 27
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean values of each sleep parameter (total sleep time, sleep efficiency, sleep latency, mid-wake time, total and percentage of deep sleep time, etc.) before cereal intake (week 0) and at weeks 4 and 8 of intake, respectively, will be calculated and their changes over time evaluated to explore the relationship between cereal intake and sleep.
- Secondary Outcome Measures
Name Time Method (1)Calculate the average values of the subjective sleep quality parameters as scored by the Subjective Sleep Assessment (OSA-MA) before cereal intake (week 0), week 4 and week 8 of intake, respectively, and evaluate the changes over time. (2) Evaluate changes in gut microbiota and short-chain fatty acids to be measured before and at 4 and 8 weeks of cereal intake. (iii) Insomnia tendency and daytime sleepiness data (Athens Insomnia Scale and Epworth Sleepiness Scale Questionnaire) collected during the pre-survey, and the questionnaire on overall mood status (POMS2 short version) and defecation status collected during screening will be compared with the results at 4 and 8 weeks of cereal intake to evaluate changes over time. These three points will provide an exploratory assessment of the effects of cereal intake on the intestinal environment, subjective sleep ratings, and mood state and defecation status.