UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031977 |
|---|---|
| Receipt number | R000036365 |
| Scientific Title | Evaluation of improving effects on fasting blood glucose of the test food. |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2018/08/09 12:10:08 |
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Basic information
Public title
Evaluation of improving effects on fasting blood glucose of the test food.
Acronym
Evaluation of improving effects on fasting blood glucose of the test food.
Scientific Title
Evaluation of improving effects on fasting blood glucose of the test food.
Scientific Title:Acronym
Evaluation of improving effects on fasting blood glucose of the test food.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines improving effects on fasting blood glucose of the test food for 12weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose
Key secondary outcomes
Immunoreactive insulin,
Homeostasis model assessment of insulin resistance,
Incremental blood glucose area under the curve.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 4 packages of the test food per day for 12 weeks.
Interventions/Control_2
Intake of 4 packages of the placebo food per day for 12 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Aged between 20 and 59 years old at consent acquisition.
(2)Subjects whose fasting blood glucose is 100-125 mg/dL or whose blood glucose is 140-199mg/dL (at 120 minutes of glucose tolerance test).
(3)Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria
(1)Subjects using medical products.
(2)Subjects who have a habit of ingesting medicine, health-promoting foods, foods for specified health uses, health foods that may affect this study.
(3)Females who are pregnant or lactating, or who could become pregnant or lactating during test period.
(4)Subjects who have a history of heart failure,liver failure, kidney failure, or digestive system disease.
(5)Subjects who excessively take alcohol.
(6)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers).
(7)Subjects who have allergy for medicine and foods.
(8) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests.
(9) Subjects who donated over 200mL blood and/or blood components within the last one month.
(10) Males who donated over 400mL blood within the last three months.
(11) Females who donated over 400mL blood within the last four months.
(12) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(13) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(14)Subjects who are not eligible for this study for some medical reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujiwara Suguru |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
Address
4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
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
| 2018 | Year | 04 | Month | 02 | 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
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036365
