UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppressive 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)	Suppressive effect of combination of test food on the postprandial blood glucose level
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 glucose level of subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve for postprandial blood glucose level
Key secondary outcomes	Postprandial blood glucose levels and insulin levels of 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 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 glucose levels are less than 126 mg/dL. 3) Subjects whose Postprandial ingestion blood glucose levels on 30 minutes after rice 200g are more than 140 mg/dL and less than 200 mg/dL.
Key exclusion criteria	1) Subjects who routinely use medicine related to lipid metabolism. 2) Subjects whose HbA1c(NGSP) are more than 6.5% 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 test food and/or high fat meal and have extreme lactose intolerance or diarrhea. 5) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 6) Heavy user of alcohol or excessive smokers 7) Subjects who have under treatment of chronic disease and routinely uses a medicine.
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuhiko Takano
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name	clinical pharmacology center
Address	61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL	001-882-0111
Email	takano@ughp-cpc.jp

Public contact
Name of contact person	Masaya Tsubokawa
Organization	FANCL Corporation
Division name	Research Institute
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3569
Homepage URL
Email	tsubokawa_masaya@fancl.co.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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 21 Day
Anticipated trial start date	2016 Year 08 Month 24 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 08 Month 22 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027310