UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038428 |
|---|---|
| Receipt number | R000043788 |
| Scientific Title | A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food - Double Blind Randomized Placebo-Controlled Parallel Group Study - |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2019/10/29 16:10:48 |
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Basic information
Public title
A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
- Double Blind Randomized Placebo-Controlled Parallel Group Study -
Acronym
A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
Scientific Title
A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
- Double Blind Randomized Placebo-Controlled Parallel Group Study -
Scientific Title:Acronym
A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective is to evaluate the efficacy of ingestion of test food to HbA1c reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c from baseline value
Key secondary outcomes
HbA1c (measured), insulin (change and measured), insulin (change and measured), CPR(change and measured), HOMA-R, and intestinal flora (Bifidobacterium)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of inulin-containing food for 8 weeks.
Interventions/Control_2
Daily ingestion of placebo food for 8 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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Adult males from 20 to 64 years old at the time of giving consent.
(2) Individuals with HbA1c values from 5.6 to <6.5 % at the time of screening.
(3) Individuals who are available at every designated hospital visit.
(4)Individuals who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1)Individuals who have history of serious gastrointestinal disease, liver disease, kidney disease, cardiovascular disease, blood disease, endocrine system disease, or malignant neoplasm, or individuals who are suspected to have these diseases.
(2) Individuals currently taking oral medication for internal diseases or receiving medical treatment.
(3) Individuals planning to take medicine or to receive medical treatment during in this study.
(4) Individuals planning to continuously take health food product or a supplement that indicates reduction of blood glucose and/or diabetes prevention during this study.
(5) Individuals who have possibility of changing a lifestyle (i.e. night work, long travel or transfer)
(6) Individuals with excessive alcohol drinking or heavy smoking
(7) Individuals who may have allergies to Asteraceae plants in relation to the test food.
(8) Individuals currently participating or planning to participate in any other clinical studies.
(9) Individuals judged as inappropriate for the trial by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
0118820111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
0118820111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
NIHON TOUNYOU SYOKKEN 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
Medical Corporation Hokubukai Utsukushigaoka Hospital institutional review board
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
0118820111
matsuda@ughp-cpc.jp
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
医療法人北武会 美しが丘病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 29 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043788
