UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019411 |
|---|---|
| Receipt number | R000022449 |
| Scientific Title | Effect of low-caffeine green tea against sleep and stress in the middle-aged people |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2017/08/07 19:58:55 |
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Basic information
Public title
Effect of low-caffeine green tea against sleep and stress in the middle-aged people
Acronym
Sleep and stress in the middle age
Scientific Title
Effect of low-caffeine green tea against sleep and stress in the middle-aged people
Scientific Title:Acronym
Sleep and stress in the middle age
Region
| Japan |
Condition
Condition
Sleep, Stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of green tea with lowered caffeine against sleep and stress are examined in the middle-aged people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Alterations in brain waves and salivary amylase activity in the middle-aged people that drank green tea with lowered caffeine
Key secondary outcomes
Physical condition, Sleeping time, Replying to a questionnaire (subjective stress)
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
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low-caffeine green tea, for 1 week
Interventions/Control_2
Green tea, for 1 week
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Middle-aged people, who are working in Kakegawa City Hall
Obtained written informed consent from the middle-aged people before the participation
Possible to take green tea everyday
Possible to check salivary amylase activity two times per day
Possible to measure brain waves
Key exclusion criteria
Taking sleep-inducing drug and tranquilized; Smoker; Diagnosed as inadequate to participate in the study by a doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Unno |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5731
kendaiunno@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Unno |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5731
Homepage URL
kendaiunno@gmail.com
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
掛川市役所 / Kakegawa City Hall
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We examined the effects of green tea with lowered caffeine content (LCGT) on stress and quality of sleep of middle-aged individuals (n=20) in a double-blind crossover design. Standard green tea (SGT) was used as the control. The level of salivary amylase activity (sAA), a stress marker, was significantly lower in participants that consumed LCGT than in those that consumed SGT. Sleep quality was higher in participants that consumed a larger quantity of LCGT. In addition, a self-diagnostic check for accumulated fatigue was significantly lower in those participants that consumed LCGT than SGT. These results indicate that LCGT intake can reduce stress in middle-aged individuals and improve their quality of sleep. The reduction in caffeine is suggested to be a valid reason for enhancing the anti-stress effect of green tea.
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
| 2015 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Nutrients, 9, 777, 2017
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2017 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022449
