UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of test-food intakes on gut environment
Acronym	Investigation of the effects of test-food intakes on gut environment
Scientific Title	Investigation of the effects of test-food intakes on gut environment
Scientific Title:Acronym	Investigation of the effects of test-food intakes on gut environment
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to investigate some kind of effect on gut environment by the test-food ingestion for 4 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fecal IgA level
Key secondary outcomes	1. Gut microbiota 2. Gut metabolites 3. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)

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	Consumption of the test food (1 g per day) every day for 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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 80 years old. (2) Subjects who can show understanding of the study procedures and agreement with participating in the study by written informed consent prior to the study.
Key exclusion criteria	(1) Subjects who have consumed cellobiose within the last 1 month to the study start, or have a plan to consume it during this study. (2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplements and/or health foods for more than 3 times a week, which would affect the study results. (3) Subjects who have current medical history/anamnesis of immune-related diseases such as autoimmune diseases or digestive ones. (4) Pregnant, possibly pregnant, or lactating women. (5) Subjects who have an allergy to the test food. (6) Subjects who have been determined ineligible for participation, judging from the principal investigator's opinions.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Shinnosuke Middle name Last name Murakami
Organization	Metagen, Inc.
Division name	Headquarters
Zip code	997-0052
Address	246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL	+81-235-64-0330
Email	research@metagen.co.jp

Public contact
Name of contact person	1st name Shinnosuke Middle name Last name Murakami
Organization	Metagen, Inc.
Division name	Headquarters
Zip code	997-0052
Address	246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL	+81-235-64-0330
Homepage URL
Email	research@metagen.co.jp

Sponsor
Institute	Metagen, Inc.
Institute
Department

Funding Source
Organization	KAKUI 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 of Chiyoda Paramedical Care Clini
Address	2F Daiwa Building, 3-3-10 Nihonbashihongoku-cho, Chuo-ku, Tokyo 103-0021, Japan
Tel	+81-3-6225-9005
Email	IRB@cpcc.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 11 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 18 Day
Date of IRB	2022 Year 04 Month 15 Day
Anticipated trial start date	2022 Year 05 Month 12 Day
Last follow-up date	2022 Year 06 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	2022 Year 05 Month 11 Day
Last modified on	2022 Year 05 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054416

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.