UMIN-CTR Clinical Trial

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
Institute	CPCC Company Limited
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040572