UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	The intake of green tea has been demonstrated to be beneficial for the elderly. Since caffeine in green tea often disrupts sleep, many elderly people restrain to drink green tea. In this study, we investigate the effect of low-caffeine green tea against sleep and stress in the elderly.
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 elderly that drank low-caffeine green tea.
Key secondary outcomes	Physical condition, Sleeping time, Replying to a questionnaire (subjective stress)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Low-caffeine green tea, 5 cups/day, for 2 weeks
Interventions/Control_2
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The elderly in the care home "Arrangement Care Sakuragaoka" Obtained written informed consent from the elderly before the participation Possible to take green tea for 3 weeks Possible to measure brain waves for 6 days Possible to check salivary amylase activity two times daily for 3 weeks
Key exclusion criteria	Taking sleep-inducing drug and tranquilizer Smoker Diagnosed as inadequate to participate in the study by a doctor
Target sample size	10

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	Keiko Unno
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	アレンジメントケア桜ヶ丘（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 02 Day
Anticipated trial start date	2015 Year 02 Month 22 Day
Last follow-up date	2015 Year 03 Month 14 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Epidemiological and animal studies have demonstrated that ingestion of green tea enhances healthy life. However, caffeine in green tea can interfere with sleep. In this report, we examined the effect of green tea with lowered caffeine, low-caffeine green tea, on stress and sleep of the elderly. The participants (n=10, mean age 89.3 y) drank five cups/day of standard green tea for 1 week. Subsequently, they drank five cups/day of low-caffeine green tea for 2 weeks. Salivary alfa-amylase activity (sAA) was measured as a stress marker. Sleep stages were measured using a portable electroencephalography (n=7, 6 female and 1 male). The level of sAA in the morning (sAAm) was significantly lower when the participants drank low-caffeine green tea than standard green tea. While the levels of sAAm were different among individuals, lower sAAm correlated with a higher quality of sleep. In those participants whose sAAm was lowered by the ingestion of low-caffeine green tea, some sleep parameters improved. Daily ingestion of low-caffeine green tea may be a beneficial tool for improving the quality of sleep of the elderly via the suppression of stress, although further research is required to fortify this hypothesis.
Other related information	JCBN, 61, 210-216, 2017

Management information
Registered date	2015 Year 02 Month 13 Day
Last modified on	2018 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019193