UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057811 |
|---|---|
| Receipt number | R000066073 |
| Scientific Title | Evaluation test of lactobacillus-containing food intake on sleep |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/05/09 14:56:40 |
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Basic information
Public title
Evaluation test of lactobacillus-containing food intake on sleep
Acronym
Evaluation test of lactobacillus-containing food intake on sleep
Scientific Title
Evaluation test of lactobacillus-containing food intake on sleep
Scientific Title:Acronym
Evaluation test of lactobacillus-containing food intake on sleep
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify the effects of Labret's Bacillus subtilis intake on sleep in healthy Japanese adult males and females aged 18 to 80 years who have some problems or troubles with sleep, objective evaluation of sleep by measuring EEG and other bioelectrical potentials from bedtime to waking and subjective evaluation of sleep using a sleep questionnaire will be conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjective sleep quality parameters scored in the subjective sleep assessment (OSA-MA) will be averaged over 3 or 2 nights at weeks 4, 8, and 12 of the labree and placebo intake periods, respectively, to assess changes over time and intervention effects.
Key secondary outcomes
1. To evaluate the daily changes and intervention effects by calculating the average values of each sleep parameter (total sleep time, sleep efficiency, sleep onset latency, mid-wake time, total time and percentage of deep sleep time, etc.) for 3 or 2 nights at weeks 4, 8, and 12 of the B. labrata intake period and placebo intake period, respectively, and to explore the relationship between the intake of B. labrata and sleep. The relationship between the ingestion of Bacillus labrata and sleep will be examined in an exploratory manner.
2. Insomnia tendency and daytime sleepiness data (Athens Insomnia Scale, Epworth Sleepiness Scale Questionnaire), stress and cognitive function assessments will be compared with the results of 4 weeks and 8 and 12 weeks of Labret bacteria intake and placebo intake to evaluate daily changes and intervention effects. These two points will evaluate the effects of Bacillus labree intake on subjective sleep assessment, stress and cognitive function.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
During the intervention period, Group A (30 participants) will conduct a stool sample to measure the intestinal microbiota as a pre-measurement, one day before the start of intake (week 0) and on the last day of week 12 of the first intervention period and on the day before the second intervention period and the last day of week 12.In addition, sleep control will be administered from 7 days prior to the start of intake until the day the study is completed.Each participant will also consume the assigned test product, either the test food containing Bacillus subtilis Lovre or placebo, for breakfast each day (no intake during the washout period), and record the intake daily (see Test Food Summary).In addition, a sleep diary will be kept daily during the intervention period.On the fourth, eighth, and twelfth weeks of the intervention period, objective sleep assessment using EEG and other bioelectrical potential measurements from bedtime to awakening, and subjective sleep assessment using a bedtime questionnaire and an OSA-MA (On Sleep Sensation upon Awakening) questionnaire will be conducted for three consecutive days (Tuesday, Wednesday, and Thursday in principle), and on the last morning of the three-day sleep assessment period, a subjective assessment of the last one month'sOn the morning of the last day of the three-day sleep evaluation period, a subjective evaluation of sleep status, etc. (Athens Insomnia Scale, Epworth Sleepiness Scale) will be conducted.Subjects will be asked to visit the hospital at Week 0 and Week 12 of the intervention period for blood tests and urine collection.
Interventions/Control_2
During the intervention period, Group B (30 participants) will have a stool sample to measure the intestinal microflora one day before the start of intake (week 0) as a pre-measurement, as well as on the last day of week 12 of the first intervention period and on the day before and last day of week 12 of the second intervention period.In addition, sleep control will be administered from 7 days prior to the start of intake until the day the study is completed.Each participant will also consume the assigned test product, either the test food containing Bacillus subtilis Lovre or placebo, for breakfast each day (no intake during the washout period), and record the intake daily (see the test food summary).In addition, a sleep diary will be kept daily during the intervention period.On the fourth, eighth, and twelfth weeks of the intervention period, objective sleep assessment using EEG and other bioelectrical potential measurements from bedtime to awakening, and subjective sleep assessment using the Pre-Bedtime Questionnaire and the Onset of Sleep Assessment (OSA-MA) will be conducted for three consecutive days (Tuesday, Wednesday, and Thursday, in principle), and on the last morning of the three-day sleep assessment period, a subjective assessment of the last one month'sOn the morning of the last day of the three-day sleep evaluation period, a subjective evaluation of sleep status, etc. (Athens Insomnia Scale, Epworth Sleepiness Scale) will be conducted.Subjects will be asked to visit the hospital at Week 0 and Week 12 of the intervention period for blood tests and urine collection.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women between the ages of 18 and 79 (at the time of obtaining consent)
2.A person whose will can be confirmed
3.Those who have a tendency to insomnia or insomnia symptoms according to the preliminary questionnaire survey.However, those with a high risk of being diagnosed as insomniacs will be excluded.
Key exclusion criteria
1.In particular, those who have been diagnosed with insomnia, sleep apnea, or other sleep disorders and are taking pharmaceuticals such as sleep aids or insomnia medications (including OTC medications as well as prescription drugs) or receiving treatment with CPAP, mouthpieces, etc.
2.Currently receiving treatment (including medication) for any disease
3.In particular, those diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, etc.
4.Those who regularly consume Food for Specified Health Use, Food with Functional Labeling, or other food/beverage with possible functionality.
5.BMI greater than 30 (severely obese)
6.Persons primarily responsible for the care of persons in need of nursing care and infants and toddlers
7.Persons employed in late night work, shift work, or heavy labor
8.Pregnant, lactating, or intending to become pregnant
9.Those who cannot sleep alone on one bedding (futon or bed, etc.) during the examination period.
10.Those who are asked to report their normal bedtime and waking time and who have less than 6 hours of bedtime.
11.Those who are unable to comply with the loose sleep control (going to bed within +-2 hours of the reported bedtime and waking within +-2 hours of the reported waking time) during the examination period, or those who are not sleeping regularly.
12.Persons who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6:00 p.m. during the EEG measurement period and the day before the measurement period.
13.Consistently consumes more than the appropriate amount of alcohol (an average of approximately 20 g of pure alcohol or less per day*)
14.Those with extremely low activity and exercise during the day
Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Information.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sakurai |
Organization
Clinical Creative Corporation
Division name
Pharmaceuticals Division
Zip code
354-0013
Address
4-1-37 Kamimuneoka, Shiki-shi, Saitama
TEL
09067004850
s-sakurai@cli-creative.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ohno |
Organization
Clinical Creative Co., Ltd.
Division name
Pharmaceutical Development Division
Zip code
003-0026
Address
2-18-201, 3-minami, Hondori 3-chome, Shiroishi-ku, Sapporo, Hokkaido
TEL
09031166218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shinwa Pharmaceuticals Co.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
15.Persons who are unable to follow the schedule for EEG measurement and input data into the sleep diary and each questionnaire.
16.Participation in another clinical trial in the month prior to the date consent was obtained or planned participation during the study period
17.Have traveled abroad within two weeks of obtaining consent or plan to travel abroad during the examination period
18.Those who do not have a smartphone
19.Any other person who is deemed by the physician to be inappropriate to participate in this study.
Management information
Registered date
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066073
