UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029141
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

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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 or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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