UMIN-CTR Clinical Trial

Public title

Clinical Evaluation of the Efficacy of Dietary Supplement
"Sulforaphane" on Hepatic Function of Subjects

Acronym

Effects of dietary supplement "Sulforaphane" on hepatic function

Scientific Title

Clinical Evaluation of the Efficacy of Dietary Supplement
"Sulforaphane" on Hepatic Function of Subjects

Scientific Title:Acronym

Effects of dietary supplement "Sulforaphane" on hepatic function

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

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 hepatic functions of
healthy subjects.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Biomarkers of liver function(ALT, AST and gamma-GTP)
before and 4, 12, 24 weeks after the intervention
with "sulforaphane" or placebo

Key secondary outcomes

Physical parameters, Hematologic values, Blood biochemical
values, Urinalysis values, Fatigue questionnaire

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Dietary supplement "Sulforaphane"
(3 capsules/day for 24 weeks)

Interventions/Control_2

Placebo(3 capsules/day for 24 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

Age-lower limit

30

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Healthy Japanese Subjects
2) Subjects whose biomarkers of liver function are with
the following values in screening test:
a)19<ALT<31, AST<31, gamma-GTP<51
b)30<ALT<51, AST<51, gamma-GTP<101

Key exclusion criteria

1) Subjects who had serious liver disease or are suspected liver
disease
2) Subjects with heart disease, kidney disease, diabetes and other serious disease
3) Subjects who had serious disease and judge not to be suitable for this study.
4) subjects with risk of allergy regarding to this study
5) Subjects who habitually consume higher amount of alchohol
(> 60 g alcohol/day)
6) Subjects who cannot stop the use of medicinse, herbal
medicinse and health foods which may affect this study
7) Subjects who cannot take test foods following the instruction
and write daily diary
8) Subjects who are in other clinical trials, or participated in other clinical trials within 2 months
9) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period
10) Subjects who are judged unsuitable for this study by principal investigator and doctors

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Aizawa

Organization

Kagome CO.,LTD.

Division name

Innovation Division

Zip code

Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Email

Koichi_Aizawa@kagome.co.jp

Name of contact person

1st name
Middle name
Last name	Yoshitada Hira

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

RBM hamamatsucho Bldg. 9F, 1-27-12, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-6450-1910

Homepage URL

Email

info@chronos-wiz.jp

Institute

Kagome CO.,LTD.

Institute

Department

Personal name

Organization

Kagome CO.,LTD.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

HUMA R&D CORP

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

医療法人団ｹｲ・ﾒﾃﾞｨｶﾙｵﾌｨｽ TOCﾋﾞﾙ診療所(東京都)（Medical Corporation TOC Bldg. Clinic）
医療法人社団盟生会 東新宿クリニック(東京都)（Meiseikai Medical Corporation Higashi-shinjuku Clinic）
医療法人社団桜緑会 日本橋さくらクリニック(東京都)（Nihonbashi Sakura Clinic）

Date of disclosure of the study information

2016

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

09

Month

12

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

12

Day

Last modified on

2017

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027655