UMIN-CTR Clinical Trial

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

Sleep, Stress

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Keiko Unno

Institute

Department

Personal name

Organization

University of Shizuoka

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

アレンジメントケア桜ヶ丘（静岡県）

Date of disclosure of the study information

2015

Year

02

Month

22

Day

URL releasing protocol

Publication of results

Published

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

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 related information

JCBN, 61, 210-216, 2017

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