UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012855
Receipt number 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 14:40:53

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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 or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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