UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effects of test foods on the intestinal environment
Acronym	Verification of the effects of test foods on the intestinal environment
Scientific Title	Verification of the effects of test foods on the intestinal environment
Scientific Title:Acronym	Verification of the effects of test foods on the intestinal environment
Region	Japan Asia(except Japan)

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To obtain data on the improvement of the intestinal environment through the consumption of the test food for 4 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bifidobacteria, good bacteria
Key secondary outcomes	Other intestinal environment data

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	Oral intake of test food (4 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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1) Healthy Japanese males whose age is between 20 and 60 years old. 2) No gastrointestinal disease. 2) No gastrointestinal disease, and not taking any medication during treatment. 3) BMI between 20 kg/m2 and 30 kg/m2. 4) Subjects who are aware that their intestinal environment is not good, such as constipation. 5) The subjects must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.
Key exclusion criteria	1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease 2) Persons who are currently undergoing treatment for a serious illness. 3) Persons with food allergies or those who are at risk of developing allergies related to the tested food 4) Who are regularly using medicines or quasi-drugs that may affect the test items. 5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items. 6) Persons who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study. 7) Persons who are unable to restrict or discontinue foods (including alcohol) that affect the data 8) Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent 9) Who plan to participate in other clinical trials during the study period 10) Who are unable to maintain their daily lifestyle. 11) Who have difficulty consuming the study food as directed 12) Other subjects who are judged by the investigator to be unsuitable for the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ikuko Middle name Last name Sagara
Organization	Well Aging Medical Corporation D Clinic Tokyo Wellness
Division name	department of internal medicine
Zip code	100-0005
Address	1-11-1 Marunouchi, Chiyoda-ku, Tokyo Pacific Century Place Marunouchi 10F
TEL	03-6665-0502
Email	plantanikuko@gmail.com

Public contact
Name of contact person	1st name Masako Middle name Last name Mizuuchi
Organization	APO PLUS STATION CO., LTD.
Division name	Clinical Operations Department, CRO Division
Zip code	103-0027
Address	2-14-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL	03-6386-8809
Homepage URL
Email	food-contact@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	ANGFA Co.,Ltd.
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	Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address	1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japan
Tel	03-6661-9061
Email	c-irb_ug@neues.co.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	2022 Year 05 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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 26 Day
Date of IRB	2022 Year 04 Month 26 Day
Anticipated trial start date	2022 Year 05 Month 13 Day
Last follow-up date	2022 Year 07 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054425

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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