UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039385 |
|---|---|
| Receipt number | 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 | 2021/08/30 11:36:35 |
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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
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
Keikyo_Ko@kagome.co.jp
Sponsor or person
Institute
Innovation Division, Kagome Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044757
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
