UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of anti-stress effect of low-caffeine green tea on students during pharmacy practice
Title of the study (Brief title)	Anti-stress effect of low-caffeine green tea
Region	Japan

Condition
Condition	Stress
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to measure stress symptoms in students during pharmacy practice and to evaluate the efficacy of low-caffeine green tea in suppressing chronic stress, by measuring the salivary amylase activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Alteration in salivary amylase activity in students during pharmacy practice for 10 days.
Key secondary outcomes	Physical condition, Sleeping time, State-trait anxiety inventory (STAI) test, Replying to a questionnaire (subjective stress, achievement emotion)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Low-caffeine green tea
Interventions/Control_2	Placebo tea
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	22 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	Student of pharmaceutical sciences in the 5th grade, non-smoker. Obtained written informed consent from the student before participation. Possible to take 500 ml of low-caffeine green tea for 16 days. Possible to check salivary amylase activity two times daily for 10 days.
Key exclusion criteria	Taking tranquilizer(s) Smoker Diagnosed as inadequate to participate in the study by a doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Keiko Unno
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5731
Email	unno@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Keiko Unno
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5731
Homepage URL
Email	unno@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	University of Shizuoka
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	静岡県立大学（静岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 25 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2014 Year 12 Month 31 Day
Date analysis concluded	2015 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	We examined the anti-stress effect of green tea with lowered caffeine, low-caffeine green tea, on humans. The study design was a single-blind group comparison and participants (n=20) were randomly assigned to low-caffeine or placebo tea groups. To assess the anxiety of participants, the state-trait anxiety inventory test was used before pharmacy practice. The subjective stress of students was significantly lower in the low-caffeine-group than in the placebo-group during pharmacy practice. The level of salivary amylase activity, a stress marker, increased significantly after daily pharmacy practice in the placebo-group but not in the low-caffeine-group. These results suggested that the ingestion of low-caffeine green tea suppressed the excessive stress response of students.
Other related information	Biol. Pharm. Bull, 40, 902-909, 2017

Management information
Registered date	2014 Year 08 Month 25 Day
Last modified on	2017 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017386