Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students

Conditions
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Healthy Students

Intervention / Treatment
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* Dietary Supplement: Theanine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Months
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theanine<br>Experimental Comparator, theanine Taking 4 tablets of theanine two times daily for 16 days Placebo Comparator, sucrose Taking 4 tablets of sucrose two times daily for 16 days | Dietary Supplement: Theanine<br>* Taking 4 tablets of theanine two times daily for 16 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in salivary amylase activity in students with pharmacy practices |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of students deteriorated physical condition |  | 10 days | 
| Incidence of days of coming late or leaving early |  | 10 days | 
| Alterations in sleeping hours from baseline |  | 10 days | 
| Alterations in the response to a stress questionnaire from baseline |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, students, pharmacy practice, theanine, pharmacy training