UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039398 |
|---|---|
| Receipt number | R000044919 |
| Scientific Title | A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose - Double Blind Randomized Placebo-Controlled Crossover Study - |
| Date of disclosure of the study information | 2020/02/05 |
| Last modified on | 2020/02/05 15:43:15 |
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Basic information
Public title
A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
- Double Blind Randomized Placebo-Controlled Crossover Study -
Acronym
A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
Scientific Title
A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
- Double Blind Randomized Placebo-Controlled Crossover Study -
Scientific Title:Acronym
A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
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 on Suppression of Postprandial Blood Glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The area under the curve (AUC) of blood glucose (measured and variation from baseline)
Key secondary outcomes
Blood glucose (measured), blood glucose Cmax (measured and variation from baseline), AUC of insulin (measured and variation from baseline), insulin (measured and variation from baseline), insulin Cmax (measured and variation from baseline)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest the following three test foods in random order.
Test food "A": inulin-containing food "A"
Carbohydrate load: retort cooked rice(300g)
Intervals of each intervention are 5 days or more.
Interventions/Control_2
Test food "B": inulin-containing food "B"
Carbohydrate load: retort cooked rice(300g)
Interventions/Control_3
Placebo food: starch
Carbohydrate load: retort cooked rice(300g)
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 whose fasting blood glucose values are from 110 to <126 mg/dL at the time of screening, or individuals whose postprandial blood glucose values at 120 min are from 140 to <200 mg/dL in 75 g OGTT at the screening.
(3) Individuals who can make self-judgment to participate the study with their own will and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1) Individuals who have serious medical history or have undergone resection surgery of digestive tract.
(2) Individuals who have HbA1c (NGSP) values of 6.5 % or more.
(3) Individuals continuously taking medication, FOSHU or health food product that may influence the results of this study.
(4) Individuals who have allergies to Asteraceae plants and/or ingredients of the test foods or carbohydrate load.
(5) Individuals with excessive alcohol drinking or heavy smoking.
(6) Individuals judged as inappropriate for the study by the principal investigator.
Target sample size
15
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, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
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, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
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, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
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
| 2020 | Year | 02 | Month | 05 | 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
15
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 | 12 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044919
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
