UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014942 |
|---|---|
| Receipt number | R000017386 |
| Scientific Title | Randomized controlled trial of anti-stress effect of low-caffeine green tea on students during pharmacy practice |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2017/08/05 15:01:45 |
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Basic information
Public title
Randomized controlled trial of anti-stress effect of low-caffeine green tea on students during pharmacy practice
Acronym
Anti-stress effect of low-caffeine green tea
Scientific Title
Randomized controlled trial of anti-stress effect of low-caffeine green tea on students during pharmacy practice
Scientific Title:Acronym
Anti-stress effect of low-caffeine green 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 low-caffeine green tea in suppressing chronic stress, by measuring the salivary amylase activity.
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 pharmacy practice for 10 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
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low-caffeine green tea
Interventions/Control_2
Placebo tea
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
Student of pharmaceutical sciences in the 5th grade, non-smoker.
Obtained written informed consent from the student before participation.
Possible to take 500 ml of low-caffeine green tea for 16 days.
Possible to check salivary amylase activity two times daily for 10 days.
Key exclusion criteria
Taking tranquilizer(s)
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
unno@u-shizuoka-ken.ac.jp
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
unno@u-shizuoka-ken.ac.jp
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
静岡県立大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 25 | 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 anti-stress effect of green tea with lowered caffeine, low-caffeine green tea, on humans. The study design was a single-blind group comparison and participants (n=20) were randomly assigned to low-caffeine or placebo tea groups. To assess the anxiety of participants, the state-trait anxiety inventory test was used before pharmacy practice. The subjective stress of students was significantly lower in the low-caffeine-group than in the placebo-group during pharmacy practice. The level of salivary amylase activity, a stress marker, increased significantly after daily pharmacy practice in the placebo-group but not in the low-caffeine-group. These results suggested that the ingestion of low-caffeine green tea suppressed the excessive stress response of students.
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
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Biol. Pharm. Bull, 40, 902-909, 2017
Management information
Registered date
| 2014 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017386
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| Registered date | File name |
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| Registered date | File name |
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