UMIN-CTR Clinical Trial

Basic information
Public title	Study on the absorption of sulforaphane after ingesting vegetable materials
Acronym	Study on the absorption of sulforaphane after ingesting vegetable materials
Scientific Title	Study on the absorption of sulforaphane after ingesting vegetable materials
Scientific Title:Acronym	Study on the absorption of sulforaphane after ingesting vegetable materials
Region	Japan

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

Objectives
Narrative objectives1	To reveal absorption/bioavailability of sulforaphane after ingesting newly developed vegetable materials.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount and ratio of absorbed sulforaphane
Key secondary outcomes	The amount and ratio of absorbed isothiocyanates

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take a single supplement containing sulforaphane (Kagome, sulforaphane supplement).
Interventions/Control_2	Take 1 times the amount of vegetable material X containing sulforaphane once.
Interventions/Control_3	Take 1.5 times the amount of vegetable material X containing sulforaphane once.
Interventions/Control_4	Take 2 times the amount of vegetable material X containing sulforaphane once.
Interventions/Control_5	Take 2 times the amount of vegetable material Y containing sulforaphane once.
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	Healthy employee of KAGOME Co. Ltd. who agreed to participate in the examination.
Key exclusion criteria	1. Who has digestion and absorption disorder. 2. Who has smoking habit. 3. who can not refrain from using drugs, quasi-drugs, Kampo products, and health products (including supplements) that may affect laboratory values during the test period. 4. Who has food allergy to the test foods. 5. Who will get pregnant or breast-feed during the study period. 6. who can not intake test foods as instructed during the test period. 7. Who join other human studies. 8. Who are judged unsuitable for this study by principal investigator.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Ushida
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-0287-36-2935
Email	Yusuke_Ushida@kagome.co.jp

Public contact
Name of contact person	1st name QINGQIANG Middle name Last name HU
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-0287-36-2935
Homepage URL
Email	Keikyo_Ko@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)

IRB Contact (For public release)
Organization	Innovation Division, Kagome Co., Ltd.
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
Tel	+81-0287-36-2935
Email	Keikyo_Ko@kagome.co.jp

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	2020 Year 02 Month 04 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	2019 Year 12 Month 26 Day
Date of IRB	2019 Year 12 Month 13 Day
Anticipated trial start date	2020 Year 01 Month 22 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 04 Day
Last modified on	2021 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044757