UMIN-CTR Clinical Trial

Basic information
Public title	Effects of rice on blood glucose level : study 2
Acronym	Effects of rice on blood glucose level : study 2
Scientific Title	Effects of rice on blood glucose level : study 2
Scientific Title:Acronym	Effects of rice on blood glucose level : study 2
Region	Japan

Condition
Condition	healthy adult male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of rice on blood glucose level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic Index (GI)
Key secondary outcomes	Incremental area under the blood glucose response curve (IAUC) Peak of blood glucose level Transition of blood glucose level Questionnaires of test food

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	standard rice, rice a, rice f, rice e, rice d, rice c, rice b
Interventions/Control_2	standard rice, rice b, rice a, rice f, rice e, rice d, rice c
Interventions/Control_3	standard rice, rice c, rice b, rice a, rice f, rice e, rice d
Interventions/Control_4	standard rice, riced, rice c, ric eb, rice a, rice f, rice e
Interventions/Control_5	standard rice, rice e, riced, rice c, rice b, rice a, rice f
Interventions/Control_6	standard rice, rice f, rice e, rice d, rice c, rice b, rice a
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male
Key inclusion criteria	1. Japanese healthy men aged 20-50years 2. BMI of 20-25 kg/m2 3. Individuals who can visit hospital on specified days 4. Individuals whose written informed consent has been obtained
Key exclusion criteria	1.Individuals who have allergic reaction to rice, wheat, barley, egg and milk 2.Individuals who have history of severe disorder and surgical disorder 3.Individuals who have medical disorder, cardiovascular, hepatic and kidney disorder, including complication of other disorder in preliminary examination 4.Individuals suspected of infectious disorder from results immunological examination 5.Individuals who have presence or previous history of gastrointestinal disease, or surgical history for excision of the gastrointestinal tract, gastric ulcer, peptic ulcer etc. 6.Individuals who have history of thyroid disorder 7.Individuals whose fasting glucose level are not 70-109 mg/dL 8.Individuals who have a difference within 25% in the IAUC of two preliminary examinations 9.Individuals diagnosed as impaired glucose tolerance in the past year 10.Individuals who donated blood (blood donation etc.) exceeding 200 mL within 4 weeks, 400 mL within 4 months or, 1200 mL within 12 months 11.Individuals participating in any other long clinical study involving human subjects within 4 weeks or currently participating in any other clinical study involving human subjects. 12.Individuals with excessive alcohol drinking or smokers 13.Individuals who can not eat regularly 14.Individuals currently intaking medicine, health food product or a supplement 15.Individuals who have experienced a feeling of unwellness or bad physical condition by blood drawing. 16.Individuals judged inappropriate for the trial by the principal
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Mine
Organization	Ajinomoto Co., Inc.
Division name	Human health & nutrition group, Institute of food sciences & technologies
Zip code	2108681
Address	1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Email	tomoyuki_mine@ajinomoto.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Fujimura
Organization	Ajinomoto Co., Inc.
Division name	Human health & nutrition group, Institute of food sciences & technologies
Zip code	2108681
Address	1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Homepage URL
Email	naoko_fujimura@ajinomoto.com

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Clinical Support Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital ethical review committee
Address	61-1, Shinei, Kiyota-ku, Sapporo-shi, Hokkaido
Tel	011-882-0111
Email	info@csc-smo.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	医療法人　北武会　美しが丘病院

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 01 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	2019 Year 08 Month 15 Day
Date of IRB	2019 Year 08 Month 15 Day
Anticipated trial start date	2019 Year 09 Month 02 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 21 Day
Last modified on	2020 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043052