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

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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 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


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

Value
https://center6.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