UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Title of the study (Brief title)	A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to assess the effect of single ingestion of inulin-containing food on postprandial blood glucose level by performing the comparison suing cross-over study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Postprandial blood glucose level(AUC,C-Max)
Key secondary outcomes	Awareness questionnaire

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of study food substance (Once) Ingestion of control food substance (Once)
Interventions/Control_2	Ingestion of control food substance (Once) Ingestion of study food substance (Once)
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) Subjects who is healthy adults of both sexes above 20 years old- under 65 years old 2) Subjects with fasting blood glucose level under 125mg/dL, and under 199mg/dL after food load at the point of screening 3) Subjects who give consent in writing with full understanding
Key exclusion criteria	1)Subjects who has difficulties to participate this study due to hepatic, kidney, cardiac disorders, lung disorder, digestive system disorder, blood disorder, endocrine disorder, metabolic defect and other serious disorders. 2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment 3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system (except appendectomy) 4)Subjects with history of sensitivity to the ingredients of test food 5)Pregnant, lactating women or willing to be pregnancy during the study 6)Subjects who had participated in other clinical trials including drug and food within 1 month. 7)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	16

Research contact person
Name of lead principal investigator	Kouji Takata
Organization	NIHONDO Co.,Ltd.
Division name	Brand Promotion Department
Address	4-7-35 kitashinagaw,shinagawa-ku ,Tokyo,140-0001,Japan
TEL	03-3446-2011
Email	k.takata@nihondo.co.jp

Public contact
Name of contact person	Shigeru Imai
Organization	CROee.INC
Division name	Evidence Division
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	CROee.INC Evidence Division
Institute
Department

Funding Source
Organization	NIHONDO Co.,Ltd.
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	東京センタークリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 28 Day
Last follow-up date	2018 Year 04 Month 25 Day
Date of closure to data entry	2018 Year 05 Month 02 Day
Date trial data considered complete	2018 Year 05 Month 08 Day
Date analysis concluded	2018 Year 06 Month 29 Day

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

Management information
Registered date	2018 Year 03 Month 21 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036348