UMIN-CTR Clinical Trial

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 aged 20 to 60 years.
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	Single blind -investigator(s) and assessor(s) 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 500ml of the test food for 4 weeks.
Interventions/Control_2	Intake 500ml 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	20 years-old <=
Age-upper limit	60 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 are 20 years old or more and under 60 years old 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 dislike the test food. 5.Persons who regularly take medicines, specified health foods, health foods, supplements, fermented foods (e.g., yogurt, natto, beverage containing lactic acid bacteria). 6.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. 7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding.
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
Institute	Macromill, Inc.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050878