Unique ID issued by UMIN | UMIN000048881 |
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Receipt number | R000055696 |
Scientific Title | A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers |
Date of disclosure of the study information | 2022/11/07 |
Last modified on | 2023/09/13 11:19:42 |
A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers
A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers
A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers
A study to evaluate the effects of the test food intake on sleep quality in healthy volunteers
Japan |
Healthy volunteers
Not applicable | Adult |
Others
NO
To evaluate the effects of the test food intake on sleep quality
Efficacy
OSA sleep inventory MA version
St. Mary's Hospital Sleep Questionnaire, Sleep & activity tracker (sleep minutes, sleep latency, sleep efficacy, minutes of awakening during sleep, number of awakenings), Oxidative stress parameters (d-ROMs, BAP), VAS (fatigue sensation)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of test food for 2 weeks -> Washout period (2 week) -> Intake of placebo for 2 weeks
Intake of placebo for 2 weeks -> Washout period (2 week) -> Intake of test food for 2 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1)Males and females whose age of 20 years or more and less than 65 years
2)Subjects who have complaints regarding sleep
3)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
1)Subjects receiving a medical treatment for sleep disorders
2)Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3)Subjects receiving a medical treatment for chronic diseases such as diabetes, hypertension and dyslipidemia
4)Subjects who take regularly medicines and quasi-drugs having the effects on sleep quality
5)Subjects who take regularly health food (e.g. Food with Functional Claims) having the effects on sleep quality
6)Subjects whose lifestyles are irregular because of night shift or others
7)Subjects who wake up for urination 2 times or more during nocturnal sleep
8)Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more)
9)Subjects who have smoking habit
10)Subjects who have the possibility of developing allergic symptoms by the test food
11)Subjects who live with their infants less than 1 year old
12)Subjects who sleep with others in a bedroom
13)Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
14)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
15)Female subjects who are pregnant or lactating, or intending to become pregnant during the study
16)Subjects deemed unsuitable by the investigator
36
1st name | Noriaki |
Middle name | |
Last name | Komori |
DKS Co. Ltd.
R&D Headquarters
601-8391
5 Ogawara-cho, Kisshoin, Minami-ku, Kyoto
075-326-7572
nkomori@dks-web.co.jp
1st name | Mai |
Middle name | |
Last name | Hamada |
Soiken Inc.
R&D Division
560-0082
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
hamada_mai@soiken.com
Soiken Inc.
DKS Co. Ltd.
Profit organization
IRB of Fukuda Clinic
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka
06-6398-0203
fukudaclinicIRB@gmail.com
NO
医療法人弘正会ふくだ内科クリニック(大阪府)
2022 | Year | 11 | Month | 07 | Day |
Unpublished
Completed
2022 | Year | 08 | Month | 20 | Day |
2022 | Year | 08 | Month | 20 | Day |
2022 | Year | 09 | Month | 17 | Day |
2022 | Year | 12 | Month | 31 | Day |
2022 | Year | 09 | Month | 08 | Day |
2023 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055696
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