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

Healthy Students Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361204
• Other study ID #: CT2011001
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: July 14, 2013
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Months to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Students

Intervention

Dietary Supplement:
• Theanine
Taking 4 tablets of theanine two times daily for 16 days

Locations

Country	Name	City	State
Japan	University of Shizuoka	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
University of Shizuoka

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations in salivary amylase activity in students with pharmacy practices		10 days	No
Secondary	Numbers of students deteriorated physical condition		10 days	No
Secondary	Incidence of days of coming late or leaving early		10 days	No
Secondary	Alterations in sleeping hours from baseline		10 days	No
Secondary	Alterations in the response to a stress questionnaire from baseline		10 days	No