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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039385
Receipt No. R000044757
Scientific Title Study on the absorption of sulforaphane after ingesting vegetable materials
Date of disclosure of the study information 2020/02/04
Last modified on 2020/02/04

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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 Preinitiation
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
2020 Year 02 Month 04 Day


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

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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