UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of food containing plant-derived ingredient on postprandial blood glucose level-placebo-control,double-blind labeled,crossover trial
Title of the study (Brief title)	Effect of food containing plant-derived ingredient on postprandial blood glucose level
Region	Japan

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

Objectives
Narrative objectives1	To explore inhibitory effect of food containing plant-derived ingredient on postprandial blood glucose level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose level after meal until 120 minutes later
Key secondary outcomes

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	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects will take the food containing plant-derived ingredient once a day. After more than 5 days of washout period, subjects will take the food containing no plant-derived ingredient once aday
Interventions/Control_2	Subjects will take the food containing no plant-derived ingredient once aday. After more than 5 days of washout period, subjects will take the food containing plant-derived ingredient once aday
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 from 20 to 65 years of age 2) Subjects falling under any of the following A. fasting blood glucose levels are ranged 110 to 125 mg/dL B. 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL 3) Understanding the study and submitting the written informed consent before the study
Key exclusion criteria	1) With diabetes mellitus or glucose metabolism disorder 2) Females in pregnancy,lactation and scheduled pregnancy period 3) With heart disorder liver disorder,and kidney disorder 4) With previous or present cardiac disorder 5) With allergy to drugs or foods 6) Use of product affecting the data of this study,such as medicine,food for specified health use,food with function claims,supplement,diet food 7) Investigator's judgment for other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Kaori Matsuoka
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Homepage URL
Email	Kaori_Matsuoka@suntory.co.jp

Sponsor
Institute	Suntory Business Expert Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 28 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	2016 Year 05 Month 26 Day
Last modified on	2016 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025886