UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Evaluation of the Efficacy of Dietary Supplement "Sulforaphane" on Hepatic Function of Subjects
Title of the study (Brief title)	Effects of dietary supplement "Sulforaphane" on hepatic function
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
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 hepatic functions of healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Koichi Aizawa
Organization	Kagome CO.,LTD.
Division name	Innovation Division
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person	Yoshitada Hira
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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

Sponsor
Institute	Kagome CO.,LTD.
Institute
Department

Funding Source
Organization	Kagome CO.,LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	HUMA R&D CORP
Name of secondary funｄer(s)

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	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）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2017 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027655