UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032335
Receipt number R000036867
Scientific Title A study for safety evaluation of excess consumption of the test food.
Date of disclosure of the study information 2019/07/16
Last modified on 2019/01/08 07:50:21

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Basic information

Public title

A study for safety evaluation of excess consumption of the test food.

Acronym

A study for safety evaluation of excess consumption of the test food.

Scientific Title

A study for safety evaluation of excess consumption of the test food.

Scientific Title:Acronym

A study for safety evaluation of excess consumption of the test food.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety evaluation when healthy adults consume the test food three pieces (300 g) a day for 4 weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) Presence or absence of, type of, severity of and frequency of side effects and adverse events (include clinical test data).
(2) Presence or absence of abnormal variations in clinical test data.

Key secondary outcomes



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

Diagnosis

Type of intervention

Food

Interventions/Control_1

Intake of 3 test drinks per day. Each test drink containing B. lactis GCL2505(concentration of 1X10^10CFU) and inulin (2g) for 4 weeks.

Interventions/Control_2

Intake of 3 placebo drinks (not containing B. lactis GCL2505 and inulin) per day 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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Male and female aged over 20 to 59 years old when acquisition consent.
(2) Subjects who take regular meals three times a day.
(3) Subjects who can abstain from alcohol 2 days before each test.
(4) Subjects who do not repeat constipation and diarrhea on a daily basis.
(5) Subjects who do not have serious complications.
(6) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

(1) Subjects who have lactose intolerance.
(2) Subjects who can't refrain restricted and/or prohibited foods during the test.
(3) Subjects who take medications that affect intestinal environment, digestion and absorption at the time of advance inspection.
(4) Subjects who regularly use laxatives, intestinal regulator, etc.
(5) Pregnant or possibly pregnant, or lactating women.
(6) Subjects who have a history of and/or current medical history of severe diseases such as heart, liver, kidney, digestive organs, drug dependence, alcohol dependence.
(7) Subjects who excessive alcohol intake.
(8) Subjects who have extremely irregular life rhythms, and have midnight work or irregular shift work.
(9) Subjects who have previous medical history of drug and/or food allergy.
(10) Subjects who have chronic illness and regularly use medicines.
(11) Subjects who were judged unsuitable for the clinical test from the results of the blood test at advance inspection.
(12) Subjects who are participating the other clinical tests and participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(13) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(14) Males who donated over 400mL blood and/or blood components within the last three months to the current study.
(15) Females who donated over 400mL blood and/or blood components within the last four months to the current study.
(16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(18) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Suguru Fujiwara

Organization

CPCC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Ichinohe

Organization

CPCC Co., Ltd.

Division name

Sales & Planning division

Zip code


Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Ezaki Glico 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


Address


Tel


Email



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

2019 Year 07 Month 16 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

It was judged that there was no problem in safety.

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

2018 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 20 Day

Last modified on

2019 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036867


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name