UMIN-ICDS Clinical Trial

Public title

Investigation of the effects of test-food consumption on the gut environment

Acronym

Investigation of the effects of test-food consumption on the gut environment

Scientific Title

Investigation of the effects of test-food consumption on the gut environment

Scientific Title:Acronym

Investigation of the effects of test-food consumption on the gut environment

Region

Japan

Condition

None

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The effects of test food consumption for 4 weeks on gut environment will be evaluated

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gut metabolites

Key secondary outcomes

1) Gut microbiota (16S rRNA amplicon)
2) Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor of defecation)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consume 30 g/day of test food for 4 weeks

Interventions/Control_2

Consume 30 g/day of control 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

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 65 years old
(2) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study

Key exclusion criteria

(1) Subjects who are regularly consuming soy meat, soy protein, soy protein-containing food/drink/supplement, soy milk and/or soybean flour for more than 3 times a week, and unable to discontinue from the time consent is obtained
(2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplement, health foods and/or lactic acid bacteria-fermented food, which would affect the study for more than 3 times a week, and unable to maintain the amount and frequency of consumption during the study
(3) Subjects who are regularly taking medicines which would affect the study (e.g. antibiotics, laxatives) at least once a week and unable to restricted during the study (No oral administration, but ophthalmic and nasal drip are acceptable)
(4) Subjects with a current history of serious illnesses related to immunity, such as autoimmune diseases, or gastrointestinal diseases
(5) Subjects who are pregnant, lactating, or intending to become pregnant during the study period
(6) Subjects who are allergic to soybean foods
(7) Subjects who take excessive alcohol
(8) Subjects who are now under other clinical study with some kind of medicine/food, or participated in those within a month before this study, or will join those after giving informed consent to participate in this study
(9) Others who have been determined ineligible by the principal/sub investigator

Target sample size

20

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

Name of contact person

1st name	Kazuteru
Middle name
Last name	Fukuhara

Organization

SHOKUNOCHIKARA CORP.

Division name

Headquarters

Zip code

996-0033

Address

15-11, Shimokanezawa, Shinjo, Yamagata, Japan

TEL

+81-233-29-8232

Homepage URL

Email

syokuchika@gmail.com

Institute

Metagen, Inc.

Institute

Department

Personal name

Organization

SHOKUNOCHIKARA CORP.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

SHOKUNOCHIKARA CORP.

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan

Tel

+81-3-6225-9005

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

09

Month

22

Day

Date of IRB

2023

Year

09

Month

22

Day

Anticipated trial start date

2023

Year

10

Month

19

Day

Last follow-up date

2023

Year

12

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

17

Day

Last modified on

2024

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059926