UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052337 |
|---|---|
| Receipt number | R000059133 |
| Scientific Title | Effects of Continuous Tea Consumption on Sleep |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2024/09/13 10:27:52 |
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Basic information
Public title
Effects of Continuous Tea Consumption on Sleep
Acronym
Effect of Tea Leaves on Sleep
Scientific Title
Effects of Continuous Tea Consumption on Sleep
Scientific Title:Acronym
Effect of Tea Leaves on Sleep
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of tea leaves on sleep in healthy adult subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep efficiency
Key secondary outcomes
Sleep onset latency, number of awakenings in the middle of the day, and 5 factors of the OSA-MA version
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3weeks
Control food
Three times a day
Interventions/Control_2
3weeks
Test food
Three times a day
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1.Have a history of, or are currently suffering from, respiratory, gastrointestinal, hepatobiliary, hematologic, renal, endocrine, or cardiovascular disease.
2.Have a history of serious trauma or surgery within 12 weeks prior to the start of the study.
3.Subjects with a history or suspected history of allergic disease requiring any kind of treatment for food or drugs.
4.Subjects who are judged by the project leader to be regular users of blueberry leaf tea at the time of the subject's explanation.
5.Subjects who are judged by the person in charge to be taking actions to improve sleep or fatigue stress at the time of the subject's explanation.
6.Subjects who wake up in the middle of the night such as urinating during the night
7.Subjects who have been diagnosed with sleep apnea syndrome and chronic fatigue syndrome
8.Subjects who are allergic to the test food
9.Subjects who have participated in other clinical trials (including clinical trials) within 4 weeks prior to the start of intake.
10.Other subjects who are judged to be unsuitable as subjects by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Shoji |
Organization
Otsuma Women's University
Division name
Department of Food Science, Faculty of Home Economics
Zip code
102-8357
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
TEL
0352756086
shoji@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Shoji |
Organization
Otsuma Women's University
Division name
Department of Food Science, Faculty of Home Economics
Zip code
102-8357
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
TEL
0352756086
Homepage URL
shoji@otsuma.ac.jp
Sponsor or person
Institute
Otsuma Women's University
Institute
Department
Personal name
Funding Source
Organization
Miyazaki prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of Otsuma Women's University
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
Tel
0352756408
kenkyu.s@ml.otsuma.ac.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
| 2023 | Year | 09 | Month | 28 | 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
50
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
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059133
