UMIN-CTR Clinical Trial

Basic information
Public title	A study on stress reduction of students by White Leaf Tea
Acronym	Anti-stress effect of White Leaf Tea
Scientific Title	A study on stress reduction of students by White Leaf Tea
Scientific Title:Acronym	Anti-stress effect of White Leaf 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 White Leaf Tea eluted in water in suppressing chronic stress, by measuring the salivary amylase activity and subjective stress.
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 daily life at university and during pharmacy practice for 15 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	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	White Leaf Tea (3 g) for 15 days
Interventions/Control_2	Placebo tea (3 g) for 15 days
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	Students of pharmaceutical sciences in the 5th grade, non-smoker. Obtained written informed consent from the student before participation. Possible to take White Leaf Tea eluted in 500 mL water for 15 days excluding weekends and holidays. Possible to check salivary amylase activity two times daily for 15 days.
Key exclusion criteria	Taking tranquilizer(s) Diagnosed as inadequate to participate in the study by a doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Keiko Middle name Last name Unno
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5731
Email	unno@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Unno
Organization	University of Shizuoka
Division name	Tea Science Center
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5822
Homepage URL
Email	unno@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka, Japan
Institute
Department

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

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

IRB Contact (For public release)
Organization	University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka-city
Tel	054-264-5103
Email	tyous10@u-shizuoka-ken.ac.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 23 Day

Related information
URL releasing protocol	https://doi.org/10.3390/molecules25153550
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3390/molecules25153550
Number of participants that the trial has enrolled	48
Results	We examined the anti-stress effect of shaded white leaf tea (SWLT) on humans. Participants consumed the tea for 1 week prior to pharmacy practice, and continued for 10 days in the practice period. The state-trait anxiety inventory, an anxiety questionnaire, tended to be scored lower in the SWLT group than placebo, but other stress markers showed no differences. However, SWLT, which is high in caffeine and amino acids, suppressed depressant behavior in mice.
Results date posted	2020 Year 12 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 08 Month 03 Day
Baseline Characteristics	Forty-eight healthy fifth-year students from the University of Shizuoka
Participant flow	One tea bag of Shaded White Leaf Tea (SWLT) or placebo (normal green tea) (3 g of tea in bag) was steeped in 500 mL of room-temperature water. The participants drank it everyday for 17 days (before 7 days of pharmacy practice and during 10 days of pharmacy practice).
Adverse events	No
Outcome measures	Measurement of salivary amylase activity Assessment of anxiety using STAI Subjective stress using VAS A questionnaire for physical condition A questionnaire for sense of achievement
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 23 Day
Date of IRB	2018 Year 03 Month 23 Day
Anticipated trial start date	2018 Year 04 Month 09 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 17 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036277