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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035313
Receipt No. R000040238
Scientific Title Elucidation of the effect of tea-derived food materials on sleep
Date of disclosure of the study information 2018/12/19
Last modified on 2018/12/19

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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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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