Unique ID issued by UMIN | UMIN000029141 |
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Receipt number | R000033319 |
Scientific Title | Clinical Evaluation of the Effects of Dietary Sulforaphane on Sleep in Healthy Volunteers |
Date of disclosure of the study information | 2017/09/14 |
Last modified on | 2018/09/28 18:52:28 |
Clinical Evaluation of the Effects of Dietary Sulforaphane on
Sleep in Healthy Volunteers
Effects of Dietary Sulforaphane on Sleep
Clinical Evaluation of the Effects of Dietary Sulforaphane on
Sleep in Healthy Volunteers
Effects of Dietary Sulforaphane on Sleep
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
The aim of this study is to evaluate the efficacy of intervention with dietary supplement "sulforaphane" on sleep quality of healthy subjects.
Efficacy
Sleep questionnaire(Oguri-Shirakawa-Azumi sleep questionnaire, The St. Mary's Hospital sleep questionnaire, VAS) before
and 1, 2, 4 weeks after the intervention with "sulforaphane"
or placebo.
Sleep monitoring by wearable devices,
Autonomic nervous function tests,
Salivary markers(Humoral factor),
Physical parameters
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
2
Prevention
Food |
Dietary supplement "Sulforaphane"(3 capsules/day
for 4 weeks)
Placebo supplement (3 capsules/day for 4 weeks)
30 | years-old | <= |
70 | years-old | > |
Male and Female
1) Healthy Japanese adults who do not receive
any treatments
2) Subjects who are not satisfied with their sleep quality
3) Subjects who habitually consume less amount of alcohol
than avg 20 g/day
4) Subjects who can give the latest date of medical checkup
1) Subjects with heart disease, kidney disease, diabetes and other serious disease
2) Subjects who had serious disease and judge not to be
suitable for this study
3) Subjects with risk of allergy regarding to this study
4) Subjects who have irregular life style
5) Subjects who cannot stop the use of medicines, herbal
medicines and health foods which may affect sleep quality
6) Subjects who cannot take interventional foods following
instructions and write life diary
7) Subjects who are in other clinical trials, or participated in
other clinical trials within 2 months
8) Subjects who are judged unsuitable for this study by
principal investigator and doctors
15
1st name | |
Middle name | |
Last name | Yasuhiro Nishizaki |
Tokai University School of Medicine
Dept. of Clinical Health Science
143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
0463-93-1121
y-nishizaki@tokai.ac.jp
1st name | |
Middle name | |
Last name | Noriaki Kishimoto |
Tokai University School of Medicine
Dept. of Clinical Health Science
143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
0463-93-1121
kissy@tokai-u.jp
Tokai University School of Medicine
Kagome. CO., LTD.
Profit organization
NO
東海大学医学部付属病院(Tokai University Hospital)
カゴメ株式会社(Kagome. CO., LTD.)
2017 | Year | 09 | Month | 14 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 12 | Day |
2017 | Year | 09 | Month | 19 | Day |
2017 | Year | 09 | Month | 14 | Day |
2018 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033319
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