UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024017 |
|---|---|
| Receipt number | 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 09:35:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
info@chronos-wiz.jp
Sponsor or person
Institute
Kagome CO.,LTD.
Institute
Department
Personal name
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
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 |
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027655
