Unique ID issued by UMIN | UMIN000058362 |
---|---|
Receipt number | R000066721 |
Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality |
Date of disclosure of the study information | 2025/07/07 |
Last modified on | 2025/07/03 16:24:12 |
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality
Clinical study to evaluate the efficacy of the bifidobacteria on sleep quality
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality
Clinical study to evaluate the efficacy of the bifidobacteria on sleep quality
Japan |
None
Not applicable | Adult |
Others
NO
To evaluate the effect of the bifidobacteria on sleep quality in adults with sleep quality concerns
Safety,Efficacy
Sleep quality (EEG)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Oral ingestion of the test food for 8 weeks
Oral ingestion of the placebo food for 8 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Participants aged more than 20 years, less than 65 years.
2) Participants with a total score of 6 or higher on the Pittsburgh Sleep Questionnaire
1)Participants with a serious disease or a history of a serious disease
2)Participants with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence
3)Participants who have been diagnosed with sleep apnea syndrome or suspected sleep apnea syndrome (including those being treated with CPAP)
4)Participants who are currently undergoing treatment for sleep, stress, or fatigue, or using medications related to sleep, stress, or fatigue
5)Participants who cannot discontinue intake of food for specified health use, food with functional claims, food with nutrient function claims, supplements, etc. that may affect sleep during the study period
6)Participants who cannot discontinue intake of foods or supplements containing lactobacilli, bifidobacteria, oligosaccharides, etc. during the study period
7)Participants who cannot discontinue intake of caffeine-rich food and beverages, alcohol, or smoking during the period of EEG measurement from 4 hours before bedtime to sleep
8)Excessive alcohol drinkers
9)Excessive smorkers
10)Participants who have more than 3 interruptions of sleep due to urination
11)Participants who do not have fixed days off, who work day and night shifts, and who work shift work (excluding participants who have a fixed work schedule per week as housewives, part-time workers, etc.)
12)Participants who plan to travel abroad during the study period
13)Participants who are participating or intend to participate in other tests
14)Participants with a history of drug allergy or food allergy
15)Participants who may experience allergic symptoms during the study period, or who are using or intend to use drugs for allergic symptoms
16)Pregnant women, intending mothers, and lactating mothers
17)Participants with sensitive skin who may develop skin irritation from adhesive plasters or adhesive tapes
18)Participants who are judged to be inappropriate for this study by the principal investigator or the examination doctor
100
1st name | Hisao |
Middle name | |
Last name | Nakatani |
Yamaguchi Health Lab
General manager
754-0041
MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.
083-976-4095
info@yamaguchi-hl.com
1st name | Hisao |
Middle name | |
Last name | Nakatani |
Yamaguchi Health Lab
General manager
754-0041
MEDIFIT LAB 3F, 1-1-2, Ogori Reiwa, Yamaguchi-City, Yamaguchi-Pref.
083-976-4095
info@yamaguchi-hl.com
Yamaguchi Health Lab
Morinaga Milk Industry Co., Ltd.
Profit organization
Japan
Japan Conference of Clinical Research
13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo, Japan
03-6868-7022
jccr-info@jccr.jp
NO
2025 | Year | 07 | Month | 07 | Day |
Unpublished
Preinitiation
2025 | Year | 06 | Month | 09 | Day |
2025 | Year | 06 | Month | 20 | Day |
2025 | Year | 07 | Month | 14 | Day |
2025 | Year | 12 | Month | 31 | Day |
2025 | Year | 07 | Month | 03 | Day |
2025 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066721