UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047587 |
|---|---|
| Receipt number | R000054267 |
| Scientific Title | Evaluation of the impact of the probiotics-containing dairy product on sleep quality |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2022/04/25 16:41:34 |
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Basic information
Public title
Evaluation of the impact of the probiotics-containing dairy product on sleep quality
Acronym
Evaluation of the impact of the probiotics-containing dairy product on sleep quality
Scientific Title
Evaluation of the impact of the probiotics-containing dairy product on sleep quality
Scientific Title:Acronym
Evaluation of the impact of the probiotics-containing dairy product on sleep quality
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the impact of the probiotics-containing dairy product on sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective sleep feeling measured by the MA version of the OSA sleep inventory
Key secondary outcomes
Sleep electroencephalography (EEG)
Mood questionnaire (VAS)
Stress questionnaire (VAS)
Pittsburgh Sleep Quality Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Dairy product containing probiotics
1 bottle (100 mL) /day for 8 weeks
Interventions/Control_2
Dairy product without probiotics
1 bottle (100 mL) /day for 8 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Office worker
2. Subjects who are having sleep dissatisfaction
3. Subjects whose average sleep time on weekdays falls in 4 hours or more and 7 hours or less
Key exclusion criteria
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.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Doctor
Zip code
103-0021
Address
2F Daiwa Bldg. 3-3-10, Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Bldg. 3-3-10, Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
m.n@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Bldg. 3-3-10, Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2022 | Year | 05 | Month | 09 | 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
| 2022 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054267
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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