UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of staple food on the intestinal environment of healthy adults
Title of the study (Brief title)	Effect of staple food on the intestinal environment of healthy adults
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of staple food (rice or bread) on the intestinal flora
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	levels of bifidobacterium
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	No common drugs, No abnormality in the health diagnosis in one years
Key exclusion criteria	No agreement, chronic disease, common drugs, rice allergy, wheat allergy, Taking intestinal drugs and antibiotics during the study period, if there was diarrhea, fever, obvious poor health during the study period, If the short-chain fatty acid content was abnormally high.
Target sample size	20

Research contact person
Name of lead principal investigator	Kaori Ikeda
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes, Endocrinology and Nutrition
Address	54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL	0757513560
Email	krikeda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kaori Ikeda
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes, Endocrinology and Nutrition
Address	54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL	0757513560
Homepage URL
Email	krikeda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Ministry of Agriculture, Forestry and Fisheries
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Interdisciplinary fusion joint research, Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 04 Month 22 Day
Last follow-up date
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	nothing special

Management information
Registered date	2016 Year 04 Month 25 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025348