UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031778 |
|---|---|
| Receipt number | R000036277 |
| Scientific Title | A study on stress reduction of students by White Leaf Tea |
| Date of disclosure of the study information | 2018/04/23 |
| Last modified on | 2020/12/17 16:41:22 |
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Basic information
Public title
A study on stress reduction of students by White Leaf Tea
Acronym
Anti-stress effect of White Leaf Tea
Scientific Title
A study on stress reduction of students by White Leaf Tea
Scientific Title:Acronym
Anti-stress effect of White Leaf Tea
Region
| Japan |
Condition
Condition
Stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to measure stress symptoms in students during pharmacy practice and to evaluate the efficacy of White Leaf Tea eluted in water in suppressing chronic stress, by measuring the salivary amylase activity and subjective stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Alteration in salivary amylase activity in students during daily life at university and during pharmacy practice for 15 days.
Key secondary outcomes
Physical condition, Sleeping time, State-trait anxiety inventory (STAI test), replying to a questionnaire (subjective stress, achievement emotion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
White Leaf Tea (3 g) for 15 days
Interventions/Control_2
Placebo tea (3 g) for 15 days
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
| 22 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students of pharmaceutical sciences in the 5th grade, non-smoker.
Obtained written informed consent from the student before participation.
Possible to take White Leaf Tea eluted in 500 mL water for 15 days excluding weekends and holidays.
Possible to check salivary amylase activity two times daily for 15 days.
Key exclusion criteria
Taking tranquilizer(s)
Diagnosed as inadequate to participate in the study by a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Unno |
Organization
University of Shizuoka
Division name
School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5731
unno@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Unno |
Organization
University of Shizuoka
Division name
Tea Science Center
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5822
Homepage URL
unno@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, Japan
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka, Japan
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
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka-city
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
静岡県立大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/molecules25153550
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/molecules25153550
Number of participants that the trial has enrolled
48
Results
We examined the anti-stress effect of shaded white leaf tea (SWLT) on humans. Participants consumed the tea for 1 week prior to pharmacy practice, and continued for 10 days in the practice period. The state-trait anxiety inventory, an anxiety questionnaire, tended to be scored lower in the SWLT group than placebo, but other stress markers showed no differences. However, SWLT, which is high in caffeine and amino acids, suppressed depressant behavior in mice.
Results date posted
| 2020 | Year | 12 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 03 | Day |
Baseline Characteristics
Forty-eight healthy fifth-year students from the University of Shizuoka
Participant flow
One tea bag of Shaded White Leaf Tea (SWLT) or placebo (normal green tea) (3 g of tea in bag) was steeped in 500 mL of room-temperature water. The participants drank it everyday for 17 days (before 7 days of pharmacy practice and during 10 days of pharmacy practice).
Adverse events
No
Outcome measures
Measurement of salivary amylase activity
Assessment of anxiety using STAI
Subjective stress using VAS
A questionnaire for physical condition
A questionnaire for sense of achievement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036277
