UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028529
Receipt No. R000032651
Scientific Title A study on stress reduction of students by Matcha Part 2
Date of disclosure of the study information 2017/08/24
Last modified on 2019/07/25 (Ver. 4)

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Basic information
Public title A study on stress reduction of students by Matcha Part 2
Acronym Anti-stress effect of Matcha 2
Scientific Title A study on stress reduction of students by Matcha Part 2
Scientific Title:Acronym Anti-stress effect of Matcha 2
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 included in cookie 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) included in cookies 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
Persons who are allergic to butter and wheat flour
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
Email 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 School of Pharmaceutical Sciences
Zip code 422-8526
Address 52-1 Yada, Suruga-ku, Shizuoka
TEL 054-264-5731
Homepage URL
Email unno@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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 University of Shizuoka
Address 52-1 Yada, Suruga-ku, Shizuoka
Tel 054-264-5103
Email 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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 24 Day

Related information
URL releasing protocol Heliyon. 2019 May 7;5(5):e01653. doi: 10.1016/j.heliyon.2019.e01653. eCollection 2019 May.
Publication of results Published

Result
URL related to results and publications Heliyon. 2019 May 7;5(5):e01653. doi: 10.1016/j.heliyon.2019.e01653. eCollection 2019 May.
Number of participants that the trial has enrolled 36
Results 
The stress-reducing effect of matcha added to confectioneries is not clear. In animal experiment, the ratio of caffeine and epigallocatechin gallate to theanine and arginine (CE/TA) was a key indicator for the suppression of stress. The result of clinical study showed that matcha with a CE/TA ratio of 2 or less displays a stress-reducing effect, even if it is included in confectionery products.
Results date posted
2019 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 05 Month 07 Day
Baseline Characteristics 
20's
Participant flow 
After recruiting participants and giving a sufficient explanation, they were divided into 2 groups and ate cookies containing test or placebo matcha for the duration of the study.
Adverse events 
No
Outcome measures 
Salivary amylase activity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 07 Month 24 Day
Date of IRB
2017 Year 07 Month 24 Day
Anticipated trial start date
2017 Year 08 Month 08 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 03 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 08 Month 03 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032651