Unique ID issued by UMIN | UMIN000039553 |
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Receipt number | R000045104 |
Scientific Title | Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10) |
Date of disclosure of the study information | 2021/05/31 |
Last modified on | 2020/02/20 19:40:23 |
Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)
Trial of the efficacy of food ingredients on sleep quality in healthy men and women
Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)
Trial of the efficacy of food ingredients on sleep quality in healthy men and women
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To evaluate the effect of food ingredients on sleep quality
Efficacy
Sleep quality
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Intake of the test foods A (8 weeks)
Intake of the test foods B (8 weeks)
Intake of the control foods (8 weeks)
40 | years-old | <= |
65 | years-old | > |
Male and Female
1) Women and men aged 40 to 64 years.
2) Person who feels poor sleep quality.
3) Person who gets a score of 6 or higher in the Japanese version of the Pittsburgh Sleep Quality Index
4) Person who can come to the medical and inspection organizations for the measurement at the date of visiting.
5) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
1) Person who are living irregularly
2) Person whose engage in shift work.
3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
4) Presence of previous and present disease such as insomnia, sleep apnea syndrome, mental disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.
90
1st name | Norifumi |
Middle name | |
Last name | Tateishi |
SUNTORY WELLNESS LIMITED
Institute For Health Care Science
619-0284
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
050-3182-0655
Norifumi_Tateishi@suntory.co.jp
1st name | Masaru |
Middle name | |
Last name | Kominami |
SUNTORY WELLNESS LIMITED
Institute For Health Care Science
619-0284
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
050-3182-0667
Masaru_Kominami@suntory.co.jp
SUNTORY WELLNESS LIMITED
SUNTORY WELLNESS LIMITED
Self funding
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F SANWA UCHIKANDA Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
03-5297-5548
IRB@cpcc.co.jp
NO
2021 | Year | 05 | Month | 31 | Day |
Unpublished
Preinitiation
2020 | Year | 01 | Month | 17 | Day |
2020 | Year | 04 | Month | 08 | Day |
2020 | Year | 06 | Month | 10 | Day |
2020 | Year | 02 | Month | 20 | Day |
2020 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045104
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