UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy for gastrointestinal condition and safety of boiled rice with higher resistant starch content.
Acronym	Evaluation of the efficacy for gastrointestinal condition and safety of boiled rice with higher resistant starch content.
Scientific Title	Evaluation of the efficacy for gastrointestinal condition and safety of boiled rice with higher resistant starch content.
Scientific Title:Acronym	Evaluation of the efficacy for gastrointestinal condition and safety of boiled rice with higher resistant starch content.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the effects on the fecal condition, intestinal microflora, and safety of boiled rice with higher resistant starch content for long term intake.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency and fecal characteristics.
Key secondary outcomes	Safety.

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	Test food : 4 week intake of boiled rice with higher resistant starch content. ( 200 g / day )
Interventions/Control_2	Placebo food : 4 week intake of boiled rice of Koshihikari (200g / day )
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Volunteer having screening test result and questionnaire result judged to be appropriate for this study by investigator.
Key exclusion criteria	1.Diabetes under medical treatment. 2.Volunteers having diseases ( e.g. liver, kidney, heart, blood diseases, and infections requiring the notification). 3.Volunteers received gastrectomy, enterectomy, and garstro-intestinal diseases, judged to be inappropriate for this study. 4.Pregnant, woman having the possibility, and lactating women. 5.Paticipants in other clinical trial. 6.Volunteers rejected participating in this study by chief investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Watanabe
Organization	Niigata Bio-Research Park, Inc
Division name	Advisor
Zip code	956-0841
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL	0250-25-1196
Email	wataken@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Goto
Organization	Niigata Bio-Research Park, Inc
Division name	Business promotion division
Zip code	956-0841
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL	0250-25-1196
Homepage URL
Email	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization	KAMEDA SEIKA 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	Niigata Bio-Research Park, Inc
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
Tel	0250-25-1196
Email	nbrp-food-navi@nbrp.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	2017 Year 08 Month 31 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 07 Month 18 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 23 Day
Last modified on	2021 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032518