UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.
Acronym	Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.
Scientific Title	Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.
Scientific Title:Acronym	Evaluation of flow-mediated dilation response after intake of heat-moisture treated brown rice flour cracker.
Region	Japan

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

Objectives
Narrative objectives1	Comparison of flow-mediated dilation ( FMD ) response after intake of heat-moisture treated brown rice flour cracker with those of brown and polished rice flour crackers without heat-moisture treatment in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FMD value
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food : heat-moisture treated koshiibuki brown rice flour cracker / dose : 60g / eating for 10min
Interventions/Control_2	Placebo food -1 : koshiibuki brown rice flour cracker / dose : 60g / eating for 10min
Interventions/Control_3	Placebo food -2 : polished koshiibuki rice flour cracker / dose : 60g / eating for 10min
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.Those with a low fasting FMD value. 2.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, kindney, heart, blood diseases, and infections requiring the notification) 3.Volunteers received gastrectomy, enterectomy, and gastro-intestinal diseases, juded to be inappropriate for this study. 4.Pregnant, women 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	12

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Watanabe
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseases
Zip code	956-0841
Address	1 Asahimachi-dori, Chuo-ku, Niigata, Japan (951-8510)
TEL	025-368-9026
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, Japan (956-0841)
TEL	0250-25-1196
Homepage URL
Email	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization	Niigata University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization	Other
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, Japan (956-0841)
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	2018 Year 11 Month 25 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	2018 Year 10 Month 31 Day
Date of IRB	2018 Year 10 Month 22 Day
Anticipated trial start date	2018 Year 11 Month 25 Day
Last follow-up date	2019 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 15 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=R000039784