UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044533
Receipt number R000050877
Scientific Title Experimental study on the effects of the test food on the intestinal microenvironment
Date of disclosure of the study information 2021/06/21
Last modified on 2021/12/03 14:13:23

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Basic information

Public title

Experimental study on the effects of the test food on the intestinal microenvironment

Acronym

Experimental study on the effects of the test food on the intestinal microenvironment

Scientific Title

Experimental study on the effects of the test food on the intestinal microenvironment

Scientific Title:Acronym

Experimental study on the effects of the test food on the intestinal microenvironment

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The verify effect on the intestinal microenvironment when taken the test food continuously for four weeks by Japanese men and women over 40 years old.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire on defecation

Key secondary outcomes

Stool exams at the beginning of the test or after ingestion of four weeks.


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake 100ml of the test food for 4 weeks.

Interventions/Control_2

Intake 100ml of the placebo food for 4 weeks.

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

40 years-old <=

Age-upper limit


Not applicable

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 are 40 years old and over.
3.Persons whose stool frequency is 2-4 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 food.
3.Persons who regularly take large amounts of the test food.
4.Persons who regularly take medicines, specified health foods, health foods, supplements, fermented foods (e.g., yogurt, natto, beverage containing lactic acid bacteria).
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 were judged as inappropriate for study participants by the principal investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hirohito
Middle name
Last name Ishikawa

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development

Zip code

105-0004

Address

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

TEL

03-6809-2722

Email

ishikawa@hc-sys.jp


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Yoshida

Organization

Macromill, Inc.

Division name

Life Science Division

Zip code

108-0075

Address

Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN

TEL

03-6716-0700

Homepage URL


Email

koh_yoshida@macromill.com


Sponsor or person

Institute

Macromill, Inc.

Institute

Department

Personal name



Funding Source

Organization

Macromill, Inc.

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 06 Month 21 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

30

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 06 Month 14 Day

Date of IRB

2021 Year 06 Month 14 Day

Anticipated trial start date

2021 Year 06 Month 22 Day

Last follow-up date

2021 Year 08 Month 11 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 06 Month 14 Day

Last modified on

2021 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name