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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016533
Receipt No. R000019193
Scientific Title Effect of low-caffeine green tea against sleep and stress in the elderly
Date of disclosure of the study information 2015/02/22
Last modified on 2018/03/17

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Basic information
Public title Effect of low-caffeine green tea against sleep and stress in the elderly
Acronym Sleep and stress in the elderly
Scientific Title Effect of low-caffeine green tea against sleep and stress in the elderly
Scientific Title:Acronym 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
1st name
Middle name
Last name Keiko Unno
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
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
Middle name
Last name Keiko Unno
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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