UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Acronym	Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Scientific Title	Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Scientific Title:Acronym	Confirmation research on sleep improvement by ingestion of a black tea ingredient-containing tablet
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to verify some kind of sleep-improving effect, which could be induced by consumption of a black tea ingredient-containing tablet for two weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. OSA sleep inventory 2. Pittsburg sleep questionnaire
Key secondary outcomes	1. Stress Check List 30 2. Active mass 3. Self-rating Depression Scale 4. Mental age 5. Brain execution 6. Chromogranin A 7. Oxytocin 8. sIgA 9. Cortisol

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test tablet licking to the subject without chewing, four times a day (every daily meal, and before going to bed, basically).
Interventions/Control_2	Ingestion of the placebo tablet licking to the subject without chewing, four times a day (every daily meal, and before going to bed, basically).
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	46 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male/female subjects ranging in age from 30 to 45, living in Tokyo and the surrounding area. (2) Subjects spending a sleepless night (difficulty in falling asleep for not less than 30 min, in waking up perspicuously; and having a nocturnal awakening, a lack of sleeping time). (3) Subjects working for not less than 4 days a week, restricting for not less than 3.5 hours in the daytime. (4) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who do not care for a black tea very much. (2) Subjects with smoking habit. (3) Subjects being over-sensitiveness to cold, even during the summer season. (4) Subjects with nasal congestion during this trial. (5) At present, subjects with continuous medical treatment. (6) Subjects having present/previous medical history of serious diseases in liver, kidney, heart, lung, and/or blood. (7) Subjects with a remedy for their sleep disorder. (8) Subjects with high blood pressure--max of above 160 mmHg, min of above 100 mmHg--. (9) Subjects who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect their sleep during this trial. (10) Subjects who realized that the subjects themselves must be in a state of menopausal disorder. (11) Subjects planning to go on a trip, or to stay in places except homes. (12) Subjects with any difficulty in refraining from using a smartphone/cellphone/personal computer, an hour before going to bed. (13) Subjects who have any difficulty in refraining from alcohol and/or caffein, after 17 o'clock during this trial. (14) Subjects sleeping together with their family (especially in pre-school children) in a bed time. (15) Pregnant, possibly pregnant, or lactating women. (16) Subjects donated their blood components and/or whole blood (200 mL) within a month to this trial. (17) Males donated their whole blood (400 mL) within the last three months to this trial. (18) Females donated their whole blood (400 mL) within the last four months to this trial. (19) Males being collected in total of their blood (1200 mL) for the last twelve months plus in this trial. (20) Females being collected in total of their blood (800 mL) for the last twelve months plus in this trial. (21) Subjects being under the other clinical tests, or took part in those within a month before this trial. (22) Others as ineligible for participation, determined by the principal investigator's opinions.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
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	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Mitsui Norin 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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
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 04 Month 29 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	Completed
Date of protocol fixation	2021 Year 03 Month 11 Day
Date of IRB	2021 Year 03 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 29 Day
Last follow-up date	2021 Year 07 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 27 Day
Last modified on	2022 Year 04 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050102