UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035313 |
|---|---|
| Receipt number | 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 | 2021/06/21 12:26:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kokubo.toshio.fp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040238
