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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.
 
ClinicalTrials.gov Identifier: NCT01361204
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka

Tracking Information
First Submitted Date  ICMJE May 10, 2011
First Posted Date  ICMJE May 26, 2011
Last Update Posted Date July 16, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2011)
Alterations in salivary amylase activity in students with pharmacy practices [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2011)
  • Numbers of students deteriorated physical condition [ Time Frame: 10 days ]
  • Incidence of days of coming late or leaving early [ Time Frame: 10 days ]
  • Alterations in sleeping hours from baseline [ Time Frame: 10 days ]
  • Alterations in the response to a stress questionnaire from baseline [ Time Frame: 10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
Official Title  ICMJE Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy Students
Intervention  ICMJE Dietary Supplement: Theanine
Taking 4 tablets of theanine two times daily for 16 days
Study Arms  ICMJE 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
Intervention: Dietary Supplement: Theanine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Months to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01361204
Other Study ID Numbers  ICMJE CT2011001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Shizuoka
Study Sponsor  ICMJE University of Shizuoka
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Unno, Keiko University of Shizuoka
PRS Account University of Shizuoka
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP