UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044381
Receipt number R000050699
Scientific Title Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Date of disclosure of the study information 2021/06/02
Last modified on 2022/11/01 18:46:45

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Basic information

Public title

Verification of the effects induced by test-food intakes on gut microenvironment and IgA

Acronym

Verification of the effects induced by test-food intakes on gut microenvironment and IgA

Scientific Title

Verification of the effects induced by test-food intakes on gut microenvironment and IgA

Scientific Title:Acronym

Verification of the effects induced by test-food intakes on gut microenvironment and IgA

Region

Japan


Condition

Condition

Healthy male/female adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to evaluate some kind of effect on gut microenvironment and fecal IgA, 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. Nonspecific serum IgE
4. Food frequency questionnaire (short version of FFQ)
5. Body composition (body weight, internal water content, muscle mass, protein content, mineral content, body fat quantity, body fat percentage, skeletal muscle mass, basal metabolic rate, body mass index, InBody score, abdominal circumference, bone mineral content)
6. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
7. Changes in clinical examination value
8. Constipation assessment scale-mid term


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the test food (50.0 g) with milk (200 mL) to the subject every morning, for 4 weeks.

Interventions/Control_2

Ingestion of the placebo food (57.3 g) with milk (200 mL) to the subject every morning, 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 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 60.
(2)Subjects who get into a habit of having breakfast, and will be able to replace their breakfast by the test food.
(3)Subjects who have a bowel evacuation for 3 to 7 times in a week.
(4)Subjects who 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 take cereal more than 3 times a week.
(2)Subjects who have a plan or who have taken medication within a month before the trial start, which would affect the trial result.
(3)Subjects who are regularly consuming food for specified health uses, food with function claims, supplement and/or health foods which would affects the trial results for more than 3 times a week.
(4)Subjects who cannot drink milk.
(5)Subjects with lactose intolerance.
(6)Subjects who had undergone appendectomy.
(7)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(8)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(9)Subjects who are suspected of seriously chronic/acute infectious diseases.
(10)Subjects who are planning to receive vaccination during this trial.
(11)Pregnant, possibly pregnant, or lactating women.
(12)Subjects who take excessive alcohol.
(13)Subjects with smoking habit, now and/or within a year before this trial.
(14)Subjects with irregular dietary habits.
(15)Subjects whose roomer is planning to join this trial.
(16)Subjects who are planning to change their life style considerably during this trial.
(17)Subjects who have food allergies.
(18)Subjects who are now under the other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial.
(19-21)Subjects who donated their blood components and/or whole blood as below
- all subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months to this trial.
(22-23)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(24)Others who have been determined ineligible by principal/sub investigator.

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Fukuda

Organization

Metabologenomics, 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 Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo , Japan

TEL

+81-3-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

Calbee, Inc.

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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

+81-3-5297-5548

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

2021 Year 06 Month 02 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

Completed

Date of protocol fixation

2021 Year 04 Month 21 Day

Date of IRB

2021 Year 04 Month 16 Day

Anticipated trial start date

2021 Year 06 Month 02 Day

Last follow-up date

2021 Year 08 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 31 Day

Last modified on

2022 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name