UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the effect of tea-derived food materials on sleep
Acronym	The effect of tea-derived food materials on sleep
Scientific Title	Elucidation of the effect of tea-derived food materials on sleep
Scientific Title:Acronym	The effect of tea-derived food materials on sleep
Region	Japan

Condition
Condition	Health subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate the effect of tea-derived food materials on sleep.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent of sleep stages evaluated polysomnography, Energy expenditure
Key secondary outcomes

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	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A. Tea-derived food materials B. Placebo1 including caffeine C. Placebo2 Each food materials is taken for 2 weeks in the order of A, B, C, and a washout period of 2 weeks or more is set between each intake. The order of food intake is (A,B,C).
Interventions/Control_2	The order of food intake is (A,C,B).
Interventions/Control_3	The order of food intake is (B,A,C).
Interventions/Control_4	The order of food intake is (B,C,A).
Interventions/Control_5	The order of food intake is (C,A,B).
Interventions/Control_6	The order of food intake is (C,B,A).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	Healthy subject
Key exclusion criteria	Participants will be excluded from the experiment based on the following criterias. 1. Systolic blood pressure below 90mmHg 2. Currently participating or has participated in other experimental studies 4 weeks prior to the experiment day 3. Those that meet the following a. Diagnosed of heart, liver, or kidney disease b. Medical history in circulatory system diseases c. Diagnosed of diabetes d. Allergies to experimental food 4. Claustrophobic 5. Physician screened the individual out of the experiment 6. Under medication or consumes functional food and dietary supplements 7. Medical history with liver, kidney, or cardiac failures 8. Below 20 or above 60 years of age 9. Treated or currently being treated of sleep or mental disorder 10. Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am, 7-9 hours of sleep) 11. BMI less than 18.5 or greater than 25 12. Worked night shifts (after 10pm) 3 months prior to the experiment 13. Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment 14. Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more) 15. Smoker 16. Consumes more than 300mg (5 cups of 150mL) of coffee every day 17. MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type) 18. ESS score of greater than 11 19. PSQI score of greater than 5.5 20. Weighs less than 36.3kg 21. Diagnosed or suspected of intestinal atresia or poor functioning in the digestive tract 22. Problems with emissary 23. History of being conducted of gastrointestinal surgery 24. Plans on getting a nuclear magnetic resonance (NMR), magnetic resonance imaging (MRI), or other procedures involving radio wave scans during the study period 25. Those who utilize implanted device such as a pacemaker The above exclusion criteria do not apply to those conducting this research.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Yanagisawa
Organization	University of Tsukuba
Division name	International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
Address	Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL	029-853-3301
Email	yanagisawa.masa.fu@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshio Kokubo
Organization	University of Tsukuba
Division name	International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
Address	Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL	029-853-8080
Homepage URL
Email	kokubo.toshio.fp@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	The National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 12 Month 19 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	2018 Year 12 Month 06 Day
Date of IRB	2018 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 12 Month 22 Day
Last follow-up date	2020 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 19 Day
Last modified on	2021 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040238