Clinical trial NCT01361204: Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
Official title: Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Students
Keywords: stress
students
pharmacy practice
theanine
pharmacy training
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long-term practices in a hospital setting and community pharmacy might induce chronic stress in students. Alterations of salivary amylase activity will be measured in students during pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on experimental animals under chronic stress and on humans under short-term stress. The purpose of this study is to measure stress symptoms in students during long-term pharmacy practices and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the salivary amylase activity.

Detailed description: The investigators have found that theanine, an amino acid in green tea, has anti-stress and anti-aging effects using experimental animals. Mice, under chronic psychosocial stress, showed shortened longevity and brain dysfunction. However, when the mice ingested theanine, they showed normal longevity and brain function even though the mice were under psychosocial stress. These data showed that theanine has a significant anti-stress effect on mice. In addition, theanine has been reported to have an anti-stress effect on humans against short-term stress by measuring salivary amylase activity. However, the efficacy of theanine against chronic stress has not been examined. Long-term pharmacy practices might induce chronic stress in students. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of theanine ingestion in suppressing chronic stress in students during long-term pharmacy practices.

Eligibility criteria: Inclusion Criteria:

* Students of pharmaceutical sciences in the fifth grade, nonsmoker
* Obtained written informed consent from the student before participation
* Possible to take tablets for 16 days
* Possible to check salivary amylase activity two times daily for 10 days

Exclusion Criteria:

* Taking tranquilizer(s)
* Smoker
* Diagnosed as inadequate to participate in the study by a doctor

Primary outcomes:
measure: Alterations in salivary amylase activity in students with pharmacy practices
timeFrame: 10 days
Secondary outcomes:
measure: Numbers of students deteriorated physical condition
timeFrame: 10 days
measure: Incidence of days of coming late or leaving early
timeFrame: 10 days
measure: Alterations in sleeping hours from baseline
timeFrame: 10 days
measure: Alterations in the response to a stress questionnaire from baseline
timeFrame: 10 days
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: University of Shizuoka
Study officials:
affiliation: University of Shizuoka
name: Unno, Keiko
role: PRINCIPAL_INVESTIGATOR
References: