UMIN-CTR Clinical Trial

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

Abnormality of liver function

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokai University School of Medicine

Institute

Department

Personal name

Organization

Kagome Co., LTd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東海大学医学部付属東京病院（東京都）
Tokai University Tokyo Hospital (Tokyo)

Date of disclosure of the study information

2014

Year

01

Month

15

Day

URL releasing protocol

Publication of results

Published

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

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 related 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