UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Title of the study (Brief title)	Effect of test food on the postprandial blood glucose level
Region	Japan

Condition
Condition	healthy adult
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 glucose level of subjects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the curve (AUC) for postprandial blood glucose level
Key secondary outcomes	AUC for postprandial insulin level, and insulin levels and blood glucose levels at 30, 60, 90, and 120 minutes after rice ingestion

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food, and then intake of placebo after wash out period
Interventions/Control_2	Intake of placebo, and then intake 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 glucose levels are less than 126 mg/dL 3)Subjects whose HbA1c(NGSP) are less than 6.5% 4)Subjects whose postprandial blood glucose levels at 30 or 60 minutes after 200g rice ingestion are more than 140 mg/dL 5)Subjects whose postprandial blood glucose levels at 120 minutes after 200g rice ingestion are less than 200 mg/dL 6)Subjects who consent to participate in the study, and can sign the consent form
Key exclusion criteria	1)Subjects who has serious medical history or who had digestive tract resection surgery 2)Subjects who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study 3)Subjects who have allergy to the test food or rice 4)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating 5)Heavy use of alcohol or excessive smokers 6)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	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Reiko Naito
Organization	Kenkoin Medical corporation foundation
Division name	Kenkoin Clinic
Address	6-7-4, Ginza, Chuo-ku, Tokyo, Japan
TEL	03-3573-1153
Homepage URL
Email	reiko-naito@kenkoin.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

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

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

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	医療法人財団健康院　健康院クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 05 Day
Last modified on	2018 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039215