UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of the efficacy of dietary sulforaphane on lipid metabolism in postmenopausal women
Title of the study (Brief title)	Effect of sulforaphane on lipid metabolism
Region	Japan

Condition
Condition	Mild abnormality of lipid metabolism
Classification by specialty	Medicine in general
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 lipid metabolism in Postmenopausal women with mild abnormality of lipid metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biomarkers of blood lipids such as TC, LDL-C and HDL-C will be measured as primary endpoint. The changes will be compared within each group and between the treatment groups.
Key secondary outcomes	As secondary endpoints, following items will be evaluated; physical parameters, blood biochemical values, biomarkers of oxidative stress and inflammation, variety and ratio of bacteria in stool (intestinal microbiota)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Postmenopausal women whom meeting the following requirements will be included. Postmenopausal women show at least one the below values of three biomarkers of blood lipids; TC: 200 mg/dL or more LDL-C: 120 mg/dL or more HDL-C: less than 40 mg/dL (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)
Key exclusion criteria	We will exclude outpatients 1) who show the abnormal value of blood lipids (TC:260 mg/dL or more, LDL-C:180 mg/dL or more, HDL-C: less than 30 mg/dL), and then are or will be undergoing treatment for abnormal lipid metabolism 2) who regularly use hormone preparations and hypolipidemic drug, and then are judged unsuitable for this study 3) with serious liver diseases in their life or suspected liver diseases 4) with serious diseases in their life and then judged unsuitable for this study 5) with serious diseases such as heart diseases, kidney diseases, organ damage and diabetes 6) with risk of allergy 7) who habitually consume higher amount of alcohol (> avg 60 g alcohol/day) 8) who participated in other clinical trials within 2 months 9) who are judged unsuitable for this study by principal investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Satoshi Sunabori
Organization	Kagome Co., Ltd.
Division name	Innovation Division
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person	Kuniaki Ota
Organization	Nasu Red Cross Hospital
Division name	Department of Obstetrics and Gynecology
Address	1081-4 Nakadawara, Ohtawara, Tochigi, 324-8686, Japan
TEL	0287-23-1122
Homepage URL
Email	k.ota@nasu.jrc.or.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Nasu Red Cross Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Innovation Division, Kagome Co., Ltd.
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	那須赤十字病院（栃木県） Nasu Red Cross Hospital (Tochigi)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 06 Month 14 Day
Last modified on	2017 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026187