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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: July 14, 2013
Last verified: July 2013

May 10, 2011
July 14, 2013
May 2011
December 2011   (final data collection date for primary outcome measure)
Alterations in salivary amylase activity in students with pharmacy practices [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01361204 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy Students
Dietary Supplement: Theanine
Taking 4 tablets of theanine two times daily for 16 days
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
22 Months to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01361204
CT2011001
Yes
University of Shizuoka
University of Shizuoka
Not Provided
Principal Investigator: Unno, Keiko University of Shizuoka
University of Shizuoka
July 2013

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