UMIN-CTR Clinical Trial

Basic information
Public title	Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Acronym	Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Scientific Title	Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Scientific Title:Acronym	Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of blood glucose suppression effects and safety of long-term ingestion of packaged cooked rice with black rice or with barley. Evaluation of suppressive effects of amyloid beta and advanced glycation end products (AGE) .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Variables related to blood glucose control (blood glucose level, inslin, HOMA-IR, IAUCg, IAUCi (0-120min)) , safety
Key secondary outcomes	Amyloid beta, HbA1c, AGE, Acceptability

Base
Study type	Interventional

Study design
Basic design	Parallel
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 -1 :12-week intake of packaged rice cooked with black brown rice (40%), super-hard rice (40%), and koshihikari brown rice (20%), followed by high pressure treatment (200MPa).
Interventions/Control_2	Test food -2 : 12week intake of packaged rice cooked with koshihikari (50%) and barley (50%), followed by high pressure treatment (200MPa).
Interventions/Control_3	Pracebo food : 12-week intake of koshihikari packaged cooked rice .
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Volunteers of higher IAUC responders to white rice in healthy subjects, by finger - prick blood measurement at 0 (pre intake), 15, 30, 45, 60, 90 and 120min post intake of white rice. 2.Fasting plasma glucose = <140mg/dL. 3.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 severe 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.Volunteers rejected participating in this study by chief investigator.
Target sample size	36

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	Niigata University of Phamacy and Applied Life Sciences , Faculty of Applied Life 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 Higasijima, 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	2018 Year 01 Month 10 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 11 Month 08 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 10 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	2018 Year 01 Month 06 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=R000034911