Unique ID issued by UMIN | UMIN000030360 |
---|---|
Receipt number | R000034666 |
Scientific Title | A study for evaluating the effect of the intake of GABA at daytime on sleep: randomized, placebo-controlled, double blind trial, cross-over study |
Date of disclosure of the study information | 2017/12/12 |
Last modified on | 2019/06/12 13:45:38 |
A study for evaluating the effect of the intake of GABA at daytime on sleep: randomized, placebo-controlled, double blind trial, cross-over study
A study for evaluating the effect of the intake of GABA at daytime on sleep
A study for evaluating the effect of the intake of GABA at daytime on sleep: randomized, placebo-controlled, double blind trial, cross-over study
A study for evaluating the effect of the intake of GABA at daytime on sleep
Japan |
Healthy adult
Adult |
Others
NO
This study (placebo controlled) evaluates during 1 week the effect of daytime GABA intake on the quality of sleep, stress and mental fatigue for those who are dissatisfied with their sleep quality.
Efficacy
Measurement of EEG during sleep (Mesurement time: before and after the intake of the sample)
-Sleep, Stress, and Mental Fatigue: VAS
-Sleep: OSA
-Sleep: PSQI-j
(Mesurement time: before and after the intake of the sample)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of test food containing GABA once a day for 1 week
Intake of placebo without GABA once a day for 1 week
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1)Males and females from 20 to 65 years of age
2)PSQI-j score is 5 points or more
1) Subjects who routinely use food supplements or medicine containing GABA.
2) Subjects who take care for the improvement of mental fatigue, quality of sleep and stress.
3) Subjects who have been diagnosed for and who are under any medical treatment.
4) Subjects who have history of the medical treatment and who are under the medical treatment for diabetes, liver disease, kidney disease, or heart disease.
5) Subjects who are planning to become pregnant and who are lactating.
6) Subjects who are judged as unsuitable for the study by doctor for other reasons.
16
1st name | |
Middle name | |
Last name | Maya Sakashita |
Pharma Foods International Co., Ltd.
Research and Development Department
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
075-394-8605
m-sakashita@pharmafoods.co.jp
1st name | |
Middle name | |
Last name | Utano Nakamura |
Pharma Foods International Co., Ltd.
Research and Development Department
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
075-394-8605
u-nakamura@pharmafoods.co.jp
Pharma Foods International Co., Ltd.
None
Self funding
YES
FH011600100601
Nihonbashi-egawa clinical research ethical review committee
2017 | Year | 12 | Month | 12 | Day |
Unpublished
Main results already published
2017 | Year | 11 | Month | 21 | Day |
2017 | Year | 12 | Month | 08 | Day |
2017 | Year | 12 | Month | 12 | Day |
2018 | Year | 04 | Month | 01 | Day |
2017 | Year | 12 | Month | 12 | Day |
2019 | Year | 06 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034666
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |