UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041529
Receipt number R000047411
Scientific Title Confirmation test about improvements of intestinal environment and immune function by test-food intake
Date of disclosure of the study information 2021/08/26
Last modified on 2021/07/20 18:31:32

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Basic information

Public title

Confirmation test about improvements of intestinal environment and immune function by test-food intake

Acronym

Confirmation test about improvements of intestinal environment and immune function by test-food intake

Scientific Title

Confirmation test about improvements of intestinal environment and immune function by test-food intake

Scientific Title:Acronym

Confirmation test about improvements of intestinal environment and immune function by test-food intake

Region

Japan


Condition

Condition

Healthy male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether test-food intakes can improve the conditions of defecation, intestinal flora, and immune function

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Bowel movement situation (frequency, number of days, amount, nature)

2. CAS-MT

Key secondary outcomes

1. Amplicon sequence analysis of changes in the behavior of intestinal bacterial flora
2. Bowel movement situation (color, smell, abdominal muscle pressure, feeling of constipation, abdominal pain)
3. NK cell activity
4. Changes in laboratory value


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Consumption of the test food (1 drop) to the subjects after breakfast (i.e., once a day).

Interventions/Control_2

Consumption of the placebo food (1 drop) to the subjects after breakfast (i.e., once a 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Healthy male/female subjects ranging in age from 20 to 64.
(2) Subjects having their defecation within 3~5 times a week.
(3) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.

Key exclusion criteria

(1) Subjects with some kind of medical treatment continuously.
(2) Subjects who have used some kind of medicine that might affect their intestine-regulating and immune functions.
(3) Subjects who have used the following foods that might affect their intestine-regulating and immune functions;
health-specific, functional, supplemental, health foods.
(4) All through this trial, subjects who have any difficulty in refraining from having denying/restricting foods.
(5) Pregnant or possibly pregnant women, or lactating ones.
(6) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(7) Subjects with excessive alcohol intake.
(8) Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work.
(9) Subjects with previous medical history of drug and/or food allergy (especially in a soybean).
(10) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after the current trial.
(11) Subjects who donated over 200 mL of their whole blood and/or blood components within a month to the current trial.
(12) Male subjects who donated over 400 mL of their whole blood within the last three months to the current trial.
(13) Female subjects who donated over 400 mL of their whole blood within the last four months to the current trial.
(14) Male subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(15) Female subjects who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial.
(16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoko
Middle name
Last name Onodera

Organization

KOEI SCIENCE LABORATORY Co., Ltd.

Division name

Executive Managing Director

Zip code

351-0115

Address

5-1-25 Niikura, Wako-shi, Saitama 351-0115, Japan

TEL

048-647-334

Email

btob@koei-science.com


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

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

Tel

03-5297-5548

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 08 Month 26 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

2020 Year 08 Month 24 Day

Date of IRB

2020 Year 08 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 26 Day

Last follow-up date

2020 Year 12 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 24 Day

Last modified on

2021 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047411


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name