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Completed

NCT Number: NCT01361204

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

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.

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Key information

Conditions

Healthy Students

Age range

22 month–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Shizuoka

Shizuoka, 422-8526, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theanine

Dietary Supplement

Taking 4 tablets of theanine two times daily for 16 days

Primary outcomes

  1. Alterations in salivary amylase activity in students with pharmacy practices

    Time frame: 10 days

Secondary outcomes

  1. Numbers of students deteriorated physical condition

    Time frame: 10 days

  2. Incidence of days of coming late or leaving early

    Time frame: 10 days

  3. Alterations in sleeping hours from baseline

    Time frame: 10 days

  4. Alterations in the response to a stress questionnaire from baseline

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

University of Shizuoka

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 26, 2011
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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