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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026752
Receipt No. R000030714
Scientific Title Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Date of disclosure of the study information 2017/03/29
Last modified on 2017/06/01

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Basic information
Public title Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Acronym Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Scientific Title Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Scientific Title:Acronym Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effects of soybeans and yogurt intake for 2 successive weeks on intestinal environment improvement in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal environment after 2 weeks of intervention
Key secondary outcomes Defecation status, questionnaire after 2 weeks of intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Soybeans 50 g/day for 2 weeks
Interventions/Control_2 Yogurt 150 g/day for 2 weeks
Interventions/Control_3 Soybeans 50 g/day and Yogurt 150 g/day for 2 weeks
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who is 20 years old or more and under 70 years old
Key exclusion criteria 1. Persons who have chronic illness and are receiving medication
2. Persons who are allergic to soybean, yogurt
3. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
4. Persons who are pregnant, planning or hoping to be pregnant during the study period
5. Persons who are breastfeeding
6. Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Osawa
Organization Aichi Gakuin University
Division name Department of Health and Nutrition
Zip code
Address 12 Araike, Iwasaki-cho, Nisshin-shi, Aichi, Japan
TEL 0561-73-1111
Email osawat@dpc.aichi-gakuin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Maruyanagi Foods Inc.
Institute
Department

Funding Source
Organization Maruyanagi Foods Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Healthcare Systems Co., Ltd.
Aichi Gakuin University
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
2017 Year 03 Month 29 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
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
2017 Year 04 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030714

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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