Healthy StudentsNCT01361204
Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
A study testing Theanine in people with Healthy Students, run by University of Shizuoka at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 22 months to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Students
- What is being tested?
- Theanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- May 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 months to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Taking tranquilizer(s)
- Smoker
- Diagnosed as inadequate to participate in the study by a doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Theanine
- Keywords
- stress, students, pharmacy practice, theanine, pharmacy training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheanineDietary supplement
Taking 4 tablets of theanine two times daily for 16 days
| Study group | Role | What they receive |
|---|---|---|
| Theanine | Experimental | 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 Receives: Dietary Supplement: Theanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in salivary amylase activity in students with pharmacy practices
Measured: 10 days
Secondary outcomes (4)
Numbers of students deteriorated physical condition
Measured: 10 days
Incidence of days of coming late or leaving early
Measured: 10 days
Alterations in sleeping hours from baseline
Measured: 10 days
Alterations in the response to a stress questionnaire from baseline
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Shizuoka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Unno, Keiko, Principal investigator, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361204
- Sponsor's protocol ID
- CT2011001
- Status last verified
- Jul 2013
- First submitted
- 10 May 2011
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Stress Symptom in Students During Long-term Pharmacy Practices and Evaluation of Anti-stress Effect of Theanine Consumption on Students
- ClinicalTrials.gov ID
- NCT01361204
- Acronym / sponsor ID
- CT2011001
- Conditions
- Healthy Students
- Keywords
- stress, students, pharmacy practice, theanine, pharmacy training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ShizuokaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theanine | Experimental | Dietary Supplement: TheanineExperimental 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 |
Who may qualify
- Ages
- 22 months to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Taking tranquilizer(s)
- Smoker
- Diagnosed as inadequate to participate in the study by a doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheanineTaking 4 tablets of theanine two times daily for 16 days | Dietary supplement | Theanine |
Primary outcome
Alterations in salivary amylase activity in students with pharmacy practices
Time frame: 10 days
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unno, Keiko principal investigator
University of Shizuoka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theanine in people with Healthy Students, run by University of Shizuoka at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in salivary amylase activity in students with pharmacy practices (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.