UMIN-CTR Clinical Trial

Basic information
Public title	Suppressive effect of test food on the postprandial blood sugar level of glucose load -A randomized, double blind, placebo controlled, cross-over study-
Acronym	Suppressive effect of combination of test food on the postprandial blood sugar level of glucose load
Scientific Title	Suppressive effect of test food on the postprandial blood sugar level of glucose load -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym	Suppressive effect of combination of test food on the postprandial blood sugar level of glucose load
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food on the postprandial blood sugar level of glucose load in subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the curve for postprandial blood sugar level of glucose load
Key secondary outcomes	Area under the curve for postprandial insulin level and postprandial blood sugar levels of glucose load

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food, and then ingestion of placebo after wash out period.
Interventions/Control_2	Intake of placebo, and then ingestion of test food after wash out period.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females 20 to 64 years of age 2) Subjects whose fasting blood sugar levels are less than 126 mg/dL. 3) Subjects whose postprandial blood sugar levels at 120 minutes after the test food glucose load are less than 200 mg/dL.
Key exclusion criteria	1) Subjects who has serious medical history or who had digestive tract resection surgery. 2) Subjects whose HbA1c(NGSP) are more than 6.4% 3) Subjects who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study. 4) Subjects who have allergy to the test food or rice. 5) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. 6) Heavy use of alcohol or excessive smokers. 7) Subjects who is considered to be inappropriate to attend the present study by the investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideaki Hoshino
Organization	Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name	General Medicine Clinical Departments Internal Medicine Respiratory Medicine Allergy
Zip code
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL	011-868-2711
Email	shiroishi@jikkai.or.jp

Public contact
Name of contact person	1st name Middle name Last name Kosuke Suzuki
Organization	Medical Corporation Jikokai
Division name	Clinical Trial Division
Zip code
Address	7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL	011-868-2711
Homepage URL
Email	suzuki-jikoukai@e-mail.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	医療法人社団 慈昂会 白石内科クリニック

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 14 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 12 Month 21 Day
Date of IRB	2018 Year 12 Month 21 Day
Anticipated trial start date	2019 Year 01 Month 15 Day
Last follow-up date	2019 Year 03 Month 28 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 12 Month 27 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040170