Evaluation of the impact of the probiotics-containing dairy product on sleep quality
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000047587
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 84
Not provided
1. Subjects who have any clinically significant disease or allergies to foods and drugs which in the investigator's opinion could interfere with the safety of study participants or with the results of the study. 2. Subjects who are currently receiving drug treatment. 3. Subjects who are making an attempt to improve stress, sleep, and fatigue by taking functional foods or receiving therapies. 4. Subjects who are in living condition that can disturb their own sleep. 5. Subjects who have smoking habits. 6. Subjects who daily take excessive alcohol. 7. Subjects who have exercise habits during night time and are unable to finish an exercise by 2 hours before bedtime. 8. Subjects who work on irregular shifts or are engaged in physical labor. 9. Subjects whose sleeping environment is likely to change significantly during the study period due to a long trip or some others. 10. Subjects having skin diseases at where electrodes for EEG measurement are to be applied, or having potential that may cause skin disorders due to the application of the electrodes. 11. Subjects using pacemakers. 12. Females who are pregnant, intend to become pregnant, or breast-feeding. 13. Subjects who have a participation in another interventional clinical study within the last 4 weeks, or are intended to participate. 14. Subjects who have tested positive for SARS-CoV-2 within the last 4 weeks. 15. Others who have been considered ineligible for the participation in the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective sleep feeling measured by the MA version of the OSA sleep inventory
- Secondary Outcome Measures
Name Time Method Sleep electroencephalography (EEG) Mood questionnaire (VAS) Stress questionnaire (VAS) Pittsburgh Sleep Quality Index