UMIN-CTR Clinical Trial

Public title

Clinical evaluation of the efficacy of dietary sulforaphane on lipid metabolism in postmenopausal women

Acronym

Effect of sulforaphane on lipid metabolism

Scientific Title

Clinical evaluation of the efficacy of dietary sulforaphane on lipid metabolism in postmenopausal women

Scientific Title:Acronym

Effect of sulforaphane on lipid metabolism

Region

Japan

Condition

Mild abnormality of lipid metabolism

Classification by specialty

Medicine in general

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 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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Sunabori

Organization

Kagome Co., Ltd.

Division name

Innovation Division

Zip code

Address

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

TEL

0287-36-2935

Email

Satoshi_Sunabori@kagome.co.jp

Name of contact person

1st name
Middle name
Last name	Kuniaki Ota

Organization

Nasu Red Cross Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1081-4 Nakadawara, Ohtawara, Tochigi, 324-8686, Japan

TEL

0287-23-1122

Homepage URL

Email

k.ota@nasu.jrc.or.jp

Institute

Department of Obstetrics and Gynecology, Nasu Red Cross Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Innovation Division, Kagome Co., Ltd.

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

那須赤十字病院（栃木県）
Nasu Red Cross Hospital (Tochigi)

Date of disclosure of the study information

2016

Year

06

Month

14

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

06

Month

10

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

14

Day

Last modified on

2017

Year

12

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026187