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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022523
Receipt No. R000025966
Scientific Title The effect of broccoli sprout on plasma concentration of dihydrotestosterone
Date of disclosure of the study information 2017/03/31
Last modified on 2017/02/28

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Basic information
Public title The effect of broccoli sprout on plasma concentration of dihydrotestosterone
Acronym The effect of broccoli sprout on plasma concentration of dihydrotestosterone
Scientific Title The effect of broccoli sprout on plasma concentration of dihydrotestosterone
Scientific Title:Acronym The effect of broccoli sprout on plasma concentration of dihydrotestosterone
Region
Japan

Condition
Condition male healthy volunteer
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To see whether daily intake of brocoli sprout decreases plasma concentration of dihydroteststerone
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes plasma dihydrotestosterone concentration after 4 weeks' daily intake of broccoli sprout
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 participants take either broccoli sprout(50g) daily for 4 weeks
Interventions/Control_2 participants take alfalfa sprout(50g) daily for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria healthy volunteer
Key exclusion criteria DM, allergy to broccoli sprout, etc
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Shimokado
Organization TOkyo Medical and Dental University
Division name Graduate School
Zip code
Address 1-5-45 Yushima, Bunkyo-ku
TEL 03-5803-5968
Email k.shimoka.vasc@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohei Shinozaki
Organization TOkyo Medical and Dental University
Division name Graduate School
Zip code
Address 1-5-45 Yushima, Bunkyo-ku
TEL 03-5803-5228
Homepage URL
Email sinovasc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental Unversity
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 東京東京医科歯科大学大学院大学 (東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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
Plasma testosterone concentrations of those who took broccoli sprout (50g/day) for one month were not significantly different from plasma testosterone concentrations of control group who took the same amount of alfalfa sprout for one month.
Neither sprout affected body weight, liver functions, insulin sensitivity or plasma lipid profile. 
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
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2016 Year 10 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 30 Day
Last modified on
2017 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025966

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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