Unique ID issued by UMIN | UMIN000033237 |
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Receipt number | R000037896 |
Scientific Title | Effect of supplements containing malic acid and magnesium oxide on sleeping - a parallel randomized trial-. |
Date of disclosure of the study information | 2019/08/03 |
Last modified on | 2019/10/01 16:48:13 |
Effect of supplements containing malic acid and magnesium oxide on sleeping - a parallel randomized trial-.
Effect of malic acid and magnesium oxide on sleeping.
Effect of supplements containing malic acid and magnesium oxide on sleeping - a parallel randomized trial-.
Effect of malic acid and magnesium oxide on sleeping.
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the efficacy of supplements containing malic acid and magnesium oxide on sleeping of healthy Japanese.
Efficacy
Confirmatory
Not applicable
Noise level during sleep
PSQI(Pittsburgh Sleep Quality Index)
POMS States-Brief Form (Profile of Mood States-Brief Form Japanese Version)
ESS(Epworth Sleepiness Scale)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
YES
No need to know
2
Prevention
Food |
Capsule containing malic acid and magnesium oxide
6 tablets/day, For the 28 days
Placebo capsule not containing magnesium malate, 6 tablets/day, For the 28 days
20 | years-old | <= |
Not applicable |
Male and Female
(1)persons who is generally judged as healthy
(2)persons who hindrance to sleep and snoring awareness
(1) persons who have changed their habitats to take supplements within past 4 weeks
(2) persons who have been treated their illness or prevention in a clinic at their informed consent
(3) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(4) persons with the medical histories of alcoholism or drug dependence
(5) persons who might be developed allergic reaction to foods.
(6) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(7) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) within past 4 weeks
(8) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(9) persons who will not be judged suitable to the participants by the investigator
30
1st name | koichiro |
Middle name | |
Last name | ohnuki |
Kindai University
Faculty of Humanity-oriented Science and Engineering
820-8555
11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
0948-22-5655
ohnuki@fuk.kindai.ac.jp
1st name | koichiro |
Middle name | |
Last name | ohnuki |
Kindai University
Faculty of Humanity-oriented Science and Engineering
820-8555
11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
0948-22-5655
ohnuki@fuk.kindai.ac.jp
Kindai University
Department of Biological & Enviromental Chemistry
Faculty of Human-Oriented Science and Engineering
Kensho Co. Ltd.
Profit organization
Ethics Committee of University Faculty of Humanity-oriented Science and Engineering
11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
0948-22-5655
ohnuki@fuk.kindai.ac.jp
NO
2019 | Year | 08 | Month | 03 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 07 | Month | 04 | Day |
2018 | Year | 08 | Month | 12 | Day |
2018 | Year | 08 | Month | 19 | Day |
2018 | Year | 08 | Month | 24 | Day |
2018 | Year | 09 | Month | 08 | Day |
2018 | Year | 07 | Month | 02 | Day |
2019 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037896
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