UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035612
Receipt number R000040572
Scientific Title A verification study for the effect of the soybean milk beverage
Date of disclosure of the study information 2019/01/27
Last modified on 2020/10/09 11:43:54

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Basic information

Public title

A verification study for the effect of the soybean milk beverage

Acronym

A verification study for the effect of the soybean milk beverage

Scientific Title

A verification study for the effect of the soybean milk beverage

Scientific Title:Acronym

A verification study for the effect of the soybean milk beverage

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify for the improving effect of intestinal environment of test beverage intake.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bacterial number and occupancy of Lactobacillus and Bifidobacterium

Key secondary outcomes

[Secondary outcomes]
1. Number of major intestinal bacteria in feces
2. Number of pathogenic bacteria in feces.
3. Constitution of microbiota in feces (such as occupancy of each bacteria, diversity of microbiota)
4. Recovery rate of Lactobacillus which contained in test beverage in feces
5. Organic acids of, moisture content of and pH of feces.
6. Spoilage product of and creatinine of urine
7. Stool frequency
8. Questionnaire about skin condition and OSA sleep inventory

[Safety outcomes]
Incidence of adverse events and of side effects


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake one bottle (100 mL) of test beverage a day, four continuous weeks.

Interventions/Control_2

Intake one bottle (100 mL) of control beverage a day, four continuous 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Males and females aged 20 to 64 years when informed consent.
2. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.

Key exclusion criteria

1.Subjects who are given continuous treatment by taking medicines.
2.Subjects who have taken medicines that may have influence to intestinal environment from a month before advance inspection.
3.Subjects who constantly use food for specified health use, functional foods, supplements, and/or healthy food having a possibility of affecting intestine regulatory action.
4.Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
5.Subjects who have previous and/or current medical history of serious disease.
6.Subjects who excessive alcohol intake.
7.Subjects who have previous and/or current medical history of drug dependence, alcohol dependence.
8.Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
9.Subjects who have previous medical history of drug and/or food, allergy, especially for milk and/or soybean milk.
10.Subjects who have constitution that tend to diarrhea if they intake dairy products and/or soybean milk products.
11.Subjects who are participating the other clinical tests, who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
12.Subjects who donated over 200mL blood and/or blood components within the last one month.
13.Males who donated over 400mL blood and/or blood components within the last three month.
14.Females who donated over 400mL blood and/or blood components within the last four month.
15.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.
16.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.
17.Others who have been determined ineligible by principal investigator.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chushin Build. 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 Masanori
Middle name
Last name Numa

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chushin Build. 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 Company Limited

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha 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 Sanwauchikanda Building, 3-3-5 Uchikanda 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

2019 Year 01 Month 27 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

120

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

2018 Year 12 Month 21 Day

Date of IRB

2018 Year 12 Month 20 Day

Anticipated trial start date

2019 Year 01 Month 27 Day

Last follow-up date

2019 Year 04 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 21 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name