UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026905 |
|---|---|
| Receipt number | R000030866 |
| Scientific Title | A study on stress reduction of students by Matcha |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2019/07/25 16:24:34 |
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Basic information
Public title
A study on stress reduction of students by Matcha
Acronym
Anti-stress effect of Matcha
Scientific Title
A study on stress reduction of students by Matcha
Scientific Title:Acronym
Anti-stress effect of Matcha
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 Matcha suspended 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
Match (3 g) for 15 days
Interventions/Control_2
Placebo Match (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 Matcha (3 g) suspended 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
40
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@-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 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
Homepage URL
unno@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka,
School of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka,
School of Pharmaceutical Sciences
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
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
| 2017 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Nutrients. 2018 Oct 10;10(10). pii: E1468. doi: 10.3390/nu10101468.
Publication of results
Published
Result
URL related to results and publications
Nutrients. 2018 Oct 10;10(10). pii: E1468. doi: 10.3390/nu10101468.
Number of participants that the trial has enrolled
39
Results
Theanine, a major amino acid in green tea, exhibits a stress-reducing effect on mice and humans. In the case of matcha, an effective stress-reducing outcome was only possible when the molar ratio of (caffeine + epigallocatechin gallate (EGCG)) / (theanine + Arginine) was less than three. Anxiety of participants, a reaction to stress, was significantly lower in the test-matcha group, which was expected to have a stress-reducing effect, than in the placebo group.
Results date posted
| 2019 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 10 | Month | 10 | Day |
Baseline Characteristics
20's
Participant flow
After recruiting participants and giving a sufficient explanation, they were divided into 2 groups and received test matcha or placebo matcha for the duration of the study.
Adverse events
No
Outcome measures
Salivary amylase activity
STAI value
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030866
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