UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of improving effects on fasting blood glucose of the test food.
Title of the study (Brief title)	Evaluation of improving effects on fasting blood glucose of the test food.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines improving effects on fasting blood glucose of the test food for 12weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fasting blood glucose
Key secondary outcomes	Immunoreactive insulin, Homeostasis model assessment of insulin resistance, Incremental blood glucose area under the curve.

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Intake of 4 packages of the test food per day for 12 weeks.
Interventions/Control_2	Intake of 4 packages of the placebo food per day for 12 weeks.
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Aged between 20 and 59 years old at consent acquisition. (2)Subjects whose fasting blood glucose is 100-125 mg/dL or whose blood glucose is 140-199mg/dL (at 120 minutes of glucose tolerance test). (3)Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria	(1)Subjects using medical products. (2)Subjects who have a habit of ingesting medicine, health-promoting foods, foods for specified health uses, health foods that may affect this study. (3)Females who are pregnant or lactating, or who could become pregnant or lactating during test period. (4)Subjects who have a history of heart failure,liver failure, kidney failure, or digestive system disease. (5)Subjects who excessively take alcohol. (6)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers). (7)Subjects who have allergy for medicine and foods. (8) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests. (9) Subjects who donated over 200mL blood and/or blood components within the last one month. (10) Males who donated over 400mL blood within the last three months. (11) Females who donated over 400mL blood within the last four months. (12) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (13) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (14)Subjects who are not eligible for this study for some medical reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	Fujiwara Suguru
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Nisshin Seifun Group Inc.
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	2018 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 02 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 03 Month 29 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036365