UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016533 |
|---|---|
| Receipt number | 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 18:53:52 |
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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
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
unno@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Keiko Unno
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019193
