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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012855
Receipt No. R000015022
Scientific Title Clinical Evaluation of the Efficacy of Dietary Sulforaphane on Male Fatty Liver Patients with Liver Dysfunction
Date of disclosure of the study information 2014/01/15
Last modified on 2015/12/01

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Basic information
Public title Clinical Evaluation of the Efficacy of Dietary Sulforaphane on Male Fatty Liver Patients with Liver Dysfunction
Acronym Effect of sulforaphane on fatty liver with liver dysfunction
Scientific Title Clinical Evaluation of the Efficacy of Dietary Sulforaphane on Male Fatty Liver Patients with Liver Dysfunction
Scientific Title:Acronym Effect of sulforaphane on fatty liver with liver dysfunction
Region
Japan

Condition
Condition Abnormality of liver function
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of intervention with dietary supplement "sulforaphane" on outpatients diagnosed as fatty liver with liver dysfunction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biomarkers of liver function such as AST, ALT and gamma-GTP will be measured as primary endpoint. If at least one of those is statistically improved in comparison with before and after the intervention with sulforaphane, the result will be considered as effective.
Key secondary outcomes As secondary endpoints, following items will be evaluated; physical parameters, blood biochemical values, biomarkers of oxidative stress and inflammation, adipocytokines, diagnosis of fatty liver (determined with ultrasound scanning and FibroScan-CAP), and subjective scores of quality of life.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Dietary supplement "sulforaphane"
Interventions/Control_2 Placebo supplement
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
70 years-old >
Gender Male
Key inclusion criteria Outpatients whom meeting the following requirements will be included.

1) Outpatients have shown at least one higher value of three biomarkers of liver function than below criterion values for 2 month;
ALT: 40 IU/L or more
AST: 35 IU/L or more
Gamma-GTP: 80 IU/L or more

2) Outpatients diagnosed as fatty liver using ultrasonography
Key exclusion criteria We will exclude outpatients

1) with serious liver diseases and suspected acute liver failure.
2) with viral hepatitis
3) with serious heart problem
4) with renal dysfunction
(serum creatinine > 2.0 mg/dL)
5) with bile duct cancer
6) without capacity of self- management of drug therapy
7) with serious diseases in their life and then judged unsuitable for this study
8) with risk of allergy
9) with suspected infectious diseases
10) who participated in other clinical trials within 2 months.
11) who habitually consume higher amount of alcohol (> avg 60 g alcohol/day)
12) who are judged unsuitable for this study by principal investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Nishizaki
Organization Tokai University School of Medicine
Division name Dept. of Clinical Health Science
Zip code
Address 1-2-5 Yoyogi, Shibuya, Tokyo 1510053, Japan
TEL 03-3370-232
Email y-nishizaki@tok.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kikuchi
Organization Tokai University School of Medicine
Division name Dept. of Gastroenterology
Zip code
Address 1-2-5 Yoyogi, Shibuya, Tokyo 1510053, Japan
TEL 03-3370-232
Homepage URL
Email kikuchim490611@yahoo.co.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Kagome Co., LTd.
Organization
Division
Category of Funding Organization Profit organization
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 東海大学医学部付属東京病院(東京都)
Tokai University Tokyo Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26604653
Number of participants that the trial has enrolled
Results
Dietary supplementation with sulforaphane precursor glucoraphanin for 2 months significantly decreased serum levels of liver function markers, ALT and g-GTP, and an established oxidative stress marker, urinary level of 8-OHdG. The reduction of urinary 8-OHdG was significantly correlated with decreased levels of both ALT and g-GTP. 
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
2014 Year 01 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2014 Year 06 Month 05 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 15 Day
Last modified on
2015 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015022

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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