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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01361204
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : July 16, 2013
Information provided by (Responsible Party):
University of Shizuoka

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.

Condition or disease Intervention/treatment Phase
Healthy Students Dietary Supplement: Theanine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Theanine

Arm Intervention/treatment
Experimental: Theanine
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
Taking 4 tablets of theanine two times daily for 16 days

Primary Outcome Measures :
  1. Alterations in salivary amylase activity in students with pharmacy practices [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Numbers of students deteriorated physical condition [ Time Frame: 10 days ]
  2. Incidence of days of coming late or leaving early [ Time Frame: 10 days ]
  3. Alterations in sleeping hours from baseline [ Time Frame: 10 days ]
  4. Alterations in the response to a stress questionnaire from baseline [ Time Frame: 10 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Months to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01361204

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University of Shizuoka
Shizuoka, Japan, 422-8526
Sponsors and Collaborators
University of Shizuoka
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Principal Investigator: Unno, Keiko University of Shizuoka
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Responsible Party: University of Shizuoka Identifier: NCT01361204    
Other Study ID Numbers: CT2011001
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by University of Shizuoka:
pharmacy practice
pharmacy training