Unique ID issued by UMIN | UMIN000044155 |
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Receipt number | R000050268 |
Scientific Title | Effect of Lactic Acid Bacterium for Sleeping Conditions |
Date of disclosure of the study information | 2021/05/14 |
Last modified on | 2022/01/31 16:12:38 |
Effect of Lactic Acid Bacterium for Sleeping Conditions
Effect of Lactic Acid Bacterium for Sleeping Conditions
Effect of Lactic Acid Bacterium for Sleeping Conditions
Effect of Lactic Acid Bacterium for Sleeping Conditions
Japan |
N/A(healthy adults)
Not applicable | Adult |
Others
NO
To evaluate the efficacy of lactic acid bacterium for sleeping conditions
Safety,Efficacy
Sleep questionnaire (OSA sleep inventory MA version, Pittsburgh Sleep Quality Index (PSQI)), VAS for stress and fatigue, total sleep time
Profile of Mood States 2nd Edition, blood cortisol, blood DHEA-S, salivary cortisol, salivary chromogranin A, salivary SIgA concentration, salivary SIgA secretory rate, sleep and heart rate data measured by activity tracker
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of the test food (1 capsule /day; 4 weeks)
Intake of the placebo (1 capsule /day; 4 weeks)
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Healthy males and females aged 20-64 years.
2. Subjects who work from Monday to Friday and have Saturday and Sunday off
3. Subjects whose PSQI score at screening is over 6 points
4. Subjects who answer "before 24 o'clock" in Question 1 of the PSQI and "4 hours or more" in Question 4 at screening
1. Subjects who are undergoing medical treatment due to chronic disease
2. Subjects with drug or food allergies
3. Subjects who are pregnant, lactating, or intending to be pregnant
4. Subjects who have more than 60 g/day of alcohol per week
5. Subjects who have or have a history of sleep apnea syndrome (SAS)
6. Subjects who have or have a history of serious hepatic disorder, renal disorder, cardiac disorder, pulmonary disorder, gastrointestinal disorder, diabetes, etc
7. Subjects with severe rhinitis
8. Subjects who have participated in other clinical trials during the month before screening, or are willing to participate in the other clinical trials during this study
9. Subjecsts who are day and night shift workers or physical labors
10. Subjects who score 10 or more on QIDS-J
11. Subjects who take at least 3 days per week of drugs or health foods that may affect this study
12. Subjects who live with infants or caregivers and sleep in an environment that prevents them from sleeping regardless of their own will
13. Subjects who cannot use smartphones to transmit and manage data from wearable devices, or who cannot download and operate apps
14. Subjects who cannot wear or operate wearable devices
15. Subjects who have a habit of taking a nap for more than an hour on weekdays
16. Subjects judged inappropriate for this study by the principal investigator
60
1st name | Takahiro |
Middle name | |
Last name | Ono |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinc
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings Co., Ltd.
Meiji Co., Ltd.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81528382485
i.takahashi@tes-h.co.jp
NO
2021 | Year | 05 | Month | 14 | Day |
Unpublished
Completed
2021 | Year | 03 | Month | 15 | Day |
2021 | Year | 03 | Month | 24 | Day |
2021 | Year | 05 | Month | 30 | Day |
2021 | Year | 07 | Month | 10 | Day |
2021 | Year | 05 | Month | 10 | Day |
2022 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050268
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