UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026752 |
|---|---|
| Receipt number | 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 17:52:32 |
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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
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
ishikawa@hc-sys.jp
Sponsor or person
Institute
Maruyanagi Foods Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030714
