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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024017
Receipt No. R000027655
Scientific Title Clinical Evaluation of the Efficacy of Dietary Supplement "Sulforaphane" on Hepatic Function of Subjects
Date of disclosure of the study information 2016/09/12
Last modified on 2017/09/13

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Basic information
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
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
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

Public contact
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

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)

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 医療法人団ケイ・メディカルオフィス TOCビル診療所(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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000027655

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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