UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026959
Receipt number R000030919
Scientific Title Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Date of disclosure of the study information 2017/04/12
Last modified on 2017/06/01 18:08:24

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Basic information

Public title

Exploratory test on the influence of bean sprout intake on postprandial blood glucose level

Acronym

Exploratory test on the influence of bean sprout intake on postprandial blood glucose level

Scientific Title

Exploratory test on the influence of bean sprout intake on postprandial blood glucose level

Scientific Title:Acronym

Exploratory test on the influence of bean sprout intake on postprandial blood glucose level

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verify the effect of bean sprouts on postprandial blood glucose levels.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic Index

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Rice 150 g

Interventions/Control_2

Rice 145 g and soybean sprout 40 g

Interventions/Control_3

Rice 145 g and petite tomato 40 g

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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who is 20 years old or more and under 50 years old
3. Persons whose BMI is 30 or less
4. Persons who do not have impaired glucose tolerance in the past one year examination
5. Persons who are not taking drugs such as antihypertensive agents

Key exclusion criteria

1. Persons who are allergic to the test food
2. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
3. Persons who are pregnant, planning or hoping to be pregnant during the study period
4. Persons who are breastfeeding
5. Persons who were judged as inappropriate for subjects by the principal investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiko Osawa

Organization

Aichi Gakuin University

Division name

Department of Health and Nutrition

Zip code


Address

12 Araike, Iwasaki-cho, Nisshin-shi, Aichi, Japan

TEL

0561-73-1111

Email

osawat@dpc.aichi-gakuin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirohito Ishikawa

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development

Zip code


Address

Nisshin Tatemono Shinbashi Bld. 7F

TEL

0368092722

Homepage URL


Email

ishikawa@hc-sys.jp


Sponsor or person

Institute

Saladcosmo Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Saladcosmo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Healthcare Systems Co., Ltd.
Aichi Gakuin University

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



Other administrative information

Date of disclosure of the study information

2017 Year 04 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

2017 Year 04 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 12 Day

Last follow-up date

2017 Year 05 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 12 Day

Last modified on

2017 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name