UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000051814
Receipt number	R000059129
Scientific Title	A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.
Date of disclosure of the study information	2023/08/04
Last modified on	2023/08/03 12:55:11

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Basic information

Public title

A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.

Acronym

A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.

Scientific Title

A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.

Scientific Title:Acronym

A study to investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.

Region

Japan

Condition

Healthy male adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To investigate the effects of a 4-week intake of the test food on the intestinal environment and the disposition of the test food after a single intake of the test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Hemodynamic tests (quercetin, quercetin conjugates, quercetin metabolites)

Key secondary outcomes

Intestinal microbiota
Intestinal metabolites
Urinary metabolites (quercetin, quercetin conjugates, quercetin metabolites)
Blood inflammatory system test (IL-6, TNF-alpha)
Blood nervous system test (serotonin)
Salivary stress test (chromogranin A, cortisol)
Skin test (stratum corneum water content, transdermal water transpiration, skin viscoelasticity)
Defecation status (frequency, number of days, amount, consistency, color, feeling of incomplete evacuation, abdominal pain)
Eating habits and lifestyle questionnaire
Body composition
POMS2 short version
abbreviated version - VAS for body sensation

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take two tablets of the test food per day -> washout -> Take two tablets of the control food per day

Interventions/Control_2

Take two tablets of the control food per day -> washout -> Take two tablets of the test food per day

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

18 years-old <=

Age-upper limit

60 years-old >

Gender

Male

Key inclusion criteria

(1) At informed consent, male subjects aged more than or equal to 18, and less than 60 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 have a plan or who have taken the food containing quercetin within a month before the trial start or during the trial.
(2)Subjects who have a plan or who have taken medication within a month before the pre-test start or during the trial, which would affect the trial result.
(3)Subjects who had undergone appendectomy.
(4)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(5)Subjects who are expected to undergo major changes in their living environment such as home and work during this trial.
(6)Subjects with irregular dietary habits.
(7)Subjects who take excessive alcohol.
(8)Subjects whose roomer is planning to join this trial.
(9)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.
(10)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11)Subjects who are allergic to medicines and test foods (related to lactic acid bacteria).
(12)Subjects who donated their blood components, and/or whole blood 200 mL within a month before the trial start.
(13)Subjects who donated their blood components, and/or whole blood 400 mL within 3 months before the trial start.
(14)Subjects whose collected blood volume within the last 12 months before the trial start would reach to 1,200 mL after adding the blood collection in this study.
(15) Others who have been determined ineligible by the principal/sub investigator.

Target sample size

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 or person

Institute

Metagen, Inc.

Institute

Department

Personal name

Funding Source

Organization

Alps Pharmaceutical Ind. 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 Clinic

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 Year 08 Month 04 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

2023 Year 07 Month 26 Day

Date of IRB

2023 Year 07 Month 21 Day

Anticipated trial start date

2023 Year 08 Month 04 Day

Last follow-up date

2023 Year 12 Month 09 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 08 Month 03 Day

Last modified on

2023 Year 08 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059129

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name