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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023134
Receipt No. R000026667
Scientific Title Study on the absorption of sulforaphane
Date of disclosure of the study information 2016/07/19
Last modified on 2018/09/20

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Basic information
Public title Study on the absorption of sulforaphane
Acronym Study on the absorption of sulforaphane
Scientific Title Study on the absorption of sulforaphane
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Sunabori
Organization Innovation Division, Kagome Co., Ltd.
Division name Nature and Wellness Research Department
Zip code
Address 17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL +81-0287-36-2935
Email Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Nobuta
Organization Innovation Division, Kagome Co., Ltd.
Division name Nature and Wellness Research Department
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 06 Month 30 Day
Date of IRB
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

Other
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

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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