UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of modified rice starch on blood glucose.
Acronym	A study for the effect of modified rice starch on blood glucose.
Scientific Title	A study for the effect of modified rice starch on blood glucose.
Scientific Title:Acronym	A study for the effect of modified rice starch on blood glucose.
Region	Japan

Condition
Condition	Healthy adult male
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of modified rice starch (W, X, Y and Z) on blood glucose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic Index (GI)
Key secondary outcomes	1 Incremental area under the curve for blood glucose 2 Blood glucose 3 Questionnaires about test food (W, X, Y and Z) except glucose solution)

Base
Study type	Interventional

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

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	rice W, rice X, rice Y, rice Z, glucose solution
Interventions/Control_2	rice X, rice Y, rice Z, glucose solution, rice W
Interventions/Control_3	rice Y, rice Z, glucose solution, rice W, rice X
Interventions/Control_4	rice Z, glucose solution, rice W, rice X, rice Y
Interventions/Control_5	glucose solution, rice W, rice X, rice Y, rice Z
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	50 years-old >
Gender	Male
Key inclusion criteria	1 Japanese healthy men aged 20-50years 2 BMI between 20-25kg/m2 3 Individuals who can visit hospital on test days 4 Individuals whose written informed consent has been obtained.
Key exclusion criteria	1 Individuals who have allergic reaction to rice, wheat, egg, milk, beef, pork, chicken, soy, apple and gelatin 2 Individuals who have history of severe disorder and surgical disorder 3 Individuals who undergo treatment for cardiovascular, hepatic and kidney disorder including complication of other disorder in preliminary examination 4 Individuals suspected of infectious disorder from results of 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 within 70-109mg/dL 8 Individuals who have a more than 25% difference in the IAUC between the two preliminary examinations 9 Individuals diagnosed as impaired glucose tolerance in the past year 10 Individuals who donated whole blood or blood components exceeding 200 mL within 4 weeks, 400 mL whole blood within 4 months or, over 1200 mL whole blood within 12 months including blood samples to be taken in this study 11 Individuals participated in any other long term food consumption clinical study within 4 weeks or currently participate in any other clinical study 12 Individuals with excessive alcohol drinking (60 g or more per day in average) or smokers 13 Individuals with extremely irregular dietary lifestyle (including whose work time is between 10 p.m. to 5 a.m.) 14 Individuals currently taking medicine, health food product or a supplement that may affect blood glucose 15 Individuals who have experienced a feeling of unwellness or bad physical condition by blood drawing. 16 Individuals who need to avoid consuming food whose origin is not disclosed due to religious reasons or other 17 Individuals judged as inappropriate for the trial by the principal investigator with other reasons
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Murakami
Organization	Ajinomoto Co., Inc.
Division name	Food Products Division Institute of Food Sciences and Technologies Wellness Value Creation Center Functional Ingredients Development Group
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-210-5844
Email	hitoshi_murakami@ajinomoto.com

Public contact
Name of contact person	1st name Daichi Middle name Last name Shindo
Organization	Ajinomoto Co., Inc.
Division name	Food Products Division Institute of Food Sciences and Technologies Wellness Value Creation Center Fu
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-210-5844
Homepage URL
Email	daichi_shindo@ajinomoto.com

Sponsor
Institute	FUKUOKA KINEN PET KENSHIN CENTER
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, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Utsukushigaoka Hospital
Address	61-1 Shinei, Kiyota Ward, Sapporo, Hokkaido
Tel	011-882-0111
Email	matsuda@ughp-cpc.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	2021 Year 05 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	2021 Year 04 Month 08 Day
Date of IRB	2021 Year 04 Month 14 Day
Anticipated trial start date	2021 Year 05 Month 15 Day
Last follow-up date	2021 Year 06 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 25 Day
Last modified on	2022 Year 10 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050442