UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Evaluation of the Effects of Dietary Sulforaphane on Sleep in Healthy Volunteers
Title of the study (Brief title)	Effects of Dietary Sulforaphane on Sleep
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of intervention with dietary supplement "sulforaphane" on sleep quality of healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	Sleep monitoring by wearable devices, Autonomic nervous function tests, Salivary markers(Humoral factor), Physical parameters

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Dietary supplement "Sulforaphane"(3 capsules/day for 4 weeks)
Interventions/Control_2	Placebo supplement (3 capsules/day for 4 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	15

Research contact person
Name of lead principal investigator	Yasuhiro Nishizaki
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL	0463-93-1121
Email	y-nishizaki@tokai.ac.jp

Public contact
Name of contact person	Noriaki Kishimoto
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL	0463-93-1121
Homepage URL
Email	kissy@tokai-u.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Kagome. CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東海大学医学部付属病院（Tokai University Hospital） カゴメ株式会社(Kagome. CO., LTD.)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 14 Day
Last modified on	2018 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033319