UMIN-ICDS Clinical Trial

Public title

Evaluation of the effect of test food intake on the gut environment due to the gut environment type

Acronym

Evaluation of the effect of test food intake on the gut environment due to the gut environment type

Scientific Title

Evaluation of the effect of test food intake on the gut environment due to the gut environment type

Scientific Title:Acronym

Evaluation of the effect of test food intake on the gut environment due to the gut environment type

Region

Japan

Condition

Healthy male/female adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluation of the effect of test food intake on the gut environment due to the gut environment type

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gut metabolites

Key secondary outcomes

Gut microbiota
Defecation status
POMS2
Athens Insomnia Scale

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of any of test food No. 1 to 5 with milk for 8 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

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 are members of Calomama app.
(3) Subjects who get into a habit of having breakfast, and will be able to replace their breakfast by the test food.
(4) Subjects who can collect and send fecal samples to the analysis agency.
(5) 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 have a plan or who have taken medication within a month before the pre-test start, which would affect the intestinal environment.
(2) Subjects who had undergone appendectomy.
(3) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(4) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial.
(5) Subjects having an irregular meal rhythm.
(6) Subjects who take excessive alcohol.
(7)Subjects whose roomer is planning to join this trial.
(8) Subjects who are planning to change their life style considerably during this trial.
(9) Subjects who cannot drink milk.
(10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11) Pregnant, possibly pregnant, or lactating women.
(12) Subjects with lactose intolerance.
(13) Subjects who have food allergies.
(14) Others who have been determined ineligible by principal/sub investigator.

Target sample size

100

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	Makoto
Middle name
Last name	Ichinohe

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan

TEL

+81-3-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

Metagen, Inc.

Institute

Department

Personal name

Organization

Calbee, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

2023

Year

12

Month

22

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

Preinitiation

Date of protocol fixation

2023

Year

12

Month

18

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

25

Day

Last follow-up date

2024

Year

06

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

22

Day

Last modified on

2023

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060721