UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023970 |
|---|---|
| Receipt number | 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 10:04:36 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027589
