UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046288
Receipt number R000052798
Scientific Title Experimental study on the health benefits of intake okara powder.
Date of disclosure of the study information 2021/12/06
Last modified on 2022/06/06 14:25:15

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Basic information

Public title

Experimental study on the health benefits of intake okara powder.

Acronym

Experimental study on the health benefits of intake okara powder.

Scientific Title

Experimental study on the health benefits of intake okara powder.

Scientific Title:Acronym

Experimental study on the health benefits of intake okara powder.

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the effect of immune system and intestinal microenvironment when taken okara powder by Adults (30 to 69 years old) .

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Urinary indoxyl sulfate at the beginning or after the intake for four weeks.

Key secondary outcomes

Questionnaire(about defecation, sleep and skin), urinary urea nitrogen and salivary IgA at the beginning or after the intake for four weeks.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake 15g or more of okara powder for four weeks.

Interventions/Control_2


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

70 years-old >

Gender

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.Adults who are 30 years old or more and under 70 years old
3.Persons whose stool frequency is 3-4 times per week

Key exclusion criteria

1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of test food
4.Persons who usually take medicine, specified health food, healthy food and supplements that may have microenvironment
5.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
6.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
7.Persons who have been judged ineligible by the study supervising physician or principal investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Mari
Middle name
Last name Shimura

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development Department

Zip code

105-0004

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Email

shimura.mari@hc-sys.jp


Public contact

Name of contact person

1st name Mari
Middle name
Last name Shimura

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development Department

Zip code

105-0004

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Homepage URL


Email

shimura.mari@hc-sys.jp


Sponsor or person

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Japan Dry Okara Association

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee of Healthcare Systems Co., Ltd.

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

Tel

03-6809-2722

Email

soumu@hc-sys.jp


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

2021 Year 12 Month 06 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

2021 Year 12 Month 06 Day

Date of IRB

2021 Year 12 Month 06 Day

Anticipated trial start date

2021 Year 12 Month 06 Day

Last follow-up date

2022 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 06 Day

Last modified on

2022 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name