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

NCT ID: NCT01361204

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-04-30

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.

Conditions

Healthy Students

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Theanine

Intervention Type: DIETARY_SUPPLEMENT

Taking 4 tablets of theanine two times daily for 16 days

Interventions

Theanine

Taking 4 tablets of theanine two times daily for 16 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 22 Months
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Shizuoka

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Unno, Keiko

Role: PRINCIPAL_INVESTIGATOR

University of Shizuoka

Locations

University of Shizuoka

Shizuoka, Shizuoka, Japan

Countries

Japan

Other Identifiers

CT2011001

Identifier Type: -

Identifier Source: org_study_id