UMIN-CTR Clinical Trial

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
Email	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
Email	m.n@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054267

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.