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
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
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
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
