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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029141
Receipt No. 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

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Basic information
Public title Clinical Evaluation of the Effects of Dietary Sulforaphane on
Sleep in Healthy Volunteers
Acronym Effects of Dietary Sulforaphane on Sleep
Scientific Title Clinical Evaluation of the Effects of Dietary Sulforaphane on
Sleep in Healthy Volunteers
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Nishizaki
Organization Tokai University School of Medicine
Division name Dept. of Clinical Health Science
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL 0463-93-1121
Email y-nishizaki@tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Kishimoto
Organization Tokai University School of Medicine
Division name Dept. of Clinical Health Science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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