UMIN-CTR Clinical Trial

Public title

Placebo-controlled, double-blind, crossover clinical trial for the effect of single intake of soybean processed food rich in beta-conglycinin on postprandial hyperlipidemia

Acronym

Effect of beta-conglycinin-rich soybean on postprandial hyperlipidemia

Scientific Title

Placebo-controlled, double-blind, crossover clinical trial for the effect of single intake of soybean processed food rich in beta-conglycinin on postprandial hyperlipidemia

Scientific Title:Acronym

Effect of beta-conglycinin-rich soybean on postprandial hyperlipidemia

Region

Japan

Condition

dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose is to evaluate the effects of high beta-conglycinin-contained soy bean for postprandial serum triglyceride by double-blind, placebo-controlled cross over test.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

TG

Key secondary outcomes

T-CHO, HDL-CHO, LDL-CHO, plasma glucose, insulin, NEFA, RLP-CHO, phospholipid, ApoB, VAS

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake beta-conglycinin-rich soybean processed food, and then ingest beta-conglycinin-poor soybean processed food after 1 week washout period.

Interventions/Control_2

Intake beta-conglycinin-poor soybean processed food, and then ingest beta-conglycinin-rich soybean processed food after 1 week washout period.

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Subjects who show high serum content of triglyceride after meal.
2)Subjects who agree to participate in the current study with written informed consent.

Key exclusion criteria

1)Subjects who are under medication for chronic ailments.
2)Subjects with serious diseases and infections.
3)Subjects with clinical history of gastrointestinal surgery.
4)Subjects with frequent complaints of post-menopausal symptoms.
5)Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
6)Subjects with serious anemia.
7)Subjects with a history of allergy to medicine and food, especially soybean.
8)Subjects routinely on supplementation which would affect the lipid metabolism.
9)Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
10)Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
11)Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
12)Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
13)Subjects who are not eligible due to physician's judgment

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code

Address

59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp

Name of contact person

1st name
Middle name
Last name	Dir. Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Health Information Science Center

Zip code

Address

59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido

TEL

011-385-4430

Homepage URL

http://biosv2.do-johodai.ac.jp/

Email

nishihira@do-johodai.ac.jp

Institute

Hokkaido Information University

Institute

Department

Personal name

Organization

Ministry of Agriculture, Forestry and Fisheries

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Kinki university faculty of agriculture,
National Agriculture and Food
Research Organization,
Nagano Research Center of Vegetable and Floricultural Science,
Asahimatsu Foods co., Ltd.,
Minami sangyo 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

北海道情報大学　保健センター(北海道)

Date of disclosure of the study information

2013

Year

10

Month

15

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

2013

Year

10

Month

11

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

30

Day

Last follow-up date

2013

Year

11

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

14

Day

Last modified on

2013

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014059