UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the absorption of sulforaphane
Title of the study (Brief title)	Study on the absorption of sulforaphane
Region	Japan

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

Objectives
Narrative objectives1	To reveal that consumption both sulforaphane glucosinolate (SGS) and specific components changes the sulforaphane absorption.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of sulforaphane metabolite in urine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects intake placebo food that contain SGS (30 mg) and not contain specific components at single.
Interventions/Control_2	The subjects intake test food that contain SGS (30 mg) and low dose of specific components at single.
Interventions/Control_3	The subjects intake test food that contain SGS (30 mg) and middle dose of specific components at single.
Interventions/Control_4	The subjects intake test food that contain SGS (30 mg) and high dose of specific components at single.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who satisfy the following conditions 1) Who do not fit key exclusion criteria 2) Who provide written informed consents
Key exclusion criteria	1. Who has digestion and absorption disorder. 2. Who has smoking habit. 3. Who take pharmaceutical or dietary supplement routinely. 4. Who has food allergy to the test foods 5. Who will get pregnant or breast-feed during the study period 6. Who join other human studies 7. Who are judged unsuitable for this study by principal investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Satoshi Sunabori
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-0287-36-2935
Email	Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person	Yukihiro Nobuta
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-0287-36-2935
Homepage URL
Email	Yukihiro_Nobuta@kagome.co.jp

Sponsor
Institute	Innovation Division, Kagome Co., Ltd.
Institute
Department

Funding Source
Organization	Innovation Division, Kagome Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 11 Month 19 Day
Date analysis concluded	2016 Year 12 Month 10 Day

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

Management information
Registered date	2016 Year 07 Month 12 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026667