UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory trial on intestinal environment improvement effect by ingestion of soybeans and yogurt
Title of the study (Brief title)	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	Toshihiko Osawa
Organization	Aichi Gakuin University
Division name	Department of Health and Nutrition
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	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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