UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism
Title of the study (Brief title)	Investigation of the effectiveness of resistant maltodextrin on glycometabolism
Region	Japan

Condition
Condition	Male and female who are aged 20 years and older and who have high HbA1c levels
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the improvement of glycometabolism such as HbA1c and fasting blood glucose levels when subjects ingest resistant maltodextrin for 24 weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)Efficacy: HbA1c (2)Safety: The incidence of side effects
Key secondary outcomes	(1)Efficacy: OGTT, GA, 1.5-AG, GLP-1, intestinal flora (2)Safety: The incidence of adverse events

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake 2 packages of resistant maltodextrin a day for 24 weeks
Interventions/Control_2	Intake 2 packages of dextrin a day for 24 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Males and females aged 20 and older. (2) Subjects whose HbA1c levels are equal to or higher than 6.0%. (3) Subjects who receive explanation for this study and voluntary give written informed consent.
Key exclusion criteria	(1) Subjects who are diagnosed as diabetes and receiving treatment. (2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect the test results. (3) Females who are pregnant or lactating, and females who have possibility of pregnancy. (4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test. (5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test. (6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test. (7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test. (10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day). (11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts. (12) Subjects who falls under any of the following criteria. (a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases). (b) Subjects who have medical history of cardiovascular diseases. (c) Subjects who are allergic to the test foods. (13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5927-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Kazuyoshi shibata
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5927-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Matsutani Chemical Industry 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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 21 Day
Anticipated trial start date	2016 Year 09 Month 13 Day
Last follow-up date	2017 Year 08 Month 24 Day
Date of closure to data entry	2017 Year 09 Month 26 Day
Date trial data considered complete	2017 Year 10 Month 11 Day
Date analysis concluded	2017 Year 11 Month 28 Day

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

Management information
Registered date	2016 Year 09 Month 07 Day
Last modified on	2018 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027589