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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023970
Receipt No. R000027589
Scientific Title Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism
Date of disclosure of the study information 2016/09/12
Last modified on 2018/06/29

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Basic information
Public title Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism
Acronym Investigation of the effectiveness of resistant maltodextrin on glycometabolism
Scientific Title Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
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
1st name
Middle name
Last name Kazuyoshi shibata
Organization CPCC Company Limited
Division name Plan Sales Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 21 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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