UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of low-caffeine green tea against sleep and stress in the middle-aged people
Title of the study (Brief title)	Sleep and stress in the middle age
Region	Japan

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

Objectives
Narrative objectives1	Effects of green tea with lowered caffeine against sleep and stress are examined in the middle-aged people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Alterations in brain waves and salivary amylase activity in the middle-aged people that drank green tea with lowered caffeine
Key secondary outcomes	Physical condition, Sleeping time, Replying to a questionnaire (subjective stress)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Low-caffeine green tea, for 1 week
Interventions/Control_2	Green tea, for 1 week
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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Middle-aged people, who are working in Kakegawa City Hall Obtained written informed consent from the middle-aged people before the participation Possible to take green tea everyday Possible to check salivary amylase activity two times per day Possible to measure brain waves
Key exclusion criteria	Taking sleep-inducing drug and tranquilized; 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	kendaiunno@gmail.com

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	kendaiunno@gmail.com

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	掛川市役所　/　Kakegawa City Hall

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 06 Day
Anticipated trial start date	2015 Year 11 Month 06 Day
Last follow-up date	2015 Year 12 Month 04 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	We examined the effects of green tea with lowered caffeine content (LCGT) on stress and quality of sleep of middle-aged individuals (n=20) in a double-blind crossover design. Standard green tea (SGT) was used as the control. The level of salivary amylase activity (sAA), a stress marker, was significantly lower in participants that consumed LCGT than in those that consumed SGT. Sleep quality was higher in participants that consumed a larger quantity of LCGT. In addition, a self-diagnostic check for accumulated fatigue was significantly lower in those participants that consumed LCGT than SGT. These results indicate that LCGT intake can reduce stress in middle-aged individuals and improve their quality of sleep. The reduction in caffeine is suggested to be a valid reason for enhancing the anti-stress effect of green tea.
Other related information	Nutrients, 9, 777, 2017

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2017 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022449