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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT01361204
First received: May 10, 2011
Last updated: May 1, 2012
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Healthy Students
 Dietary Supplement: Theanine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

Drug Information available for: Theanine
U.S. FDA Resources

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • Alterations in salivary amylase activity in students with pharmacy practices [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numbers of students deteriorated physical condition [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Incidence of days of coming late or leaving early [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Alterations in sleeping hours from baseline [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Alterations in the response to a stress questionnaire from baseline [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   22 Months to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361204

Locations
Japan
University of Shizuoka
Shizuoka, Japan, 422-8526
Sponsors and Collaborators
University of Shizuoka
Investigators
Principal Investigator: Unno, Keiko University of Shizuoka
  More Information

No publications provided

Responsible Party: University of Shizuoka
ClinicalTrials.gov Identifier: NCT01361204     History of Changes
Other Study ID Numbers: CT2011001
Study First Received: May 10, 2011
Last Updated: May 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:
stress
students
pharmacy practice
theanine
pharmacy training

ClinicalTrials.gov processed this record on May 16, 2013