UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035487 |
|---|---|
| Receipt number | R000040434 |
| Scientific Title | Randomized placebo double-blind study on improvement of blood glucose level by test food for type 2 diabetes preliminary group |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2019/11/30 15:10:07 |
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Basic information
Public title
Randomized placebo double-blind study on improvement of blood glucose level by test food for type 2 diabetes preliminary group
Acronym
Diabetes related factor improvement study by test food
Scientific Title
Randomized placebo double-blind study on improvement of blood glucose level by test food for type 2 diabetes preliminary group
Scientific Title:Acronym
Diabetes related factor improvement study by test food
Region
| Japan |
Condition
Condition
Diabetes preliminary group
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness by ingesting test food to diabetes related factor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose level, HbA1c, QOL score, AGEs measurement at 0,4,8,12 weeks, Sugar tolerance test at 0, 12 weeks
Key secondary outcomes
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
Duration: 12 weeks.
Test materials: Test food
Does: 4.5g per day.
Interventions/Control_2
Duration: 12 weeks.
Test materials: Placebo food
Does: 4.5g per day.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy subjects from 35 years old over.
2. Subjects who can visit the examination place on a fixed schedule.
3. Subjects who can cooperate with weight measurement, a questionnaire and blood sampling test.
4. Subjects who can ingest test food or placebo food dissolved with water etc., once a day during the examination.
5. Subjects who can fill up the examination record everyday.
6.HbA1c is >=5.0%, <6.4%
7.Fasting blood sugar level is 80-110 mg/dl
Key exclusion criteria
1. Subjects who have food allergy. Especially subjects who are sensitive to gelatin.
2. Subjects who have been medical history of physical disorder when they took supplements.
3. Subjects who are diabetes.
4. Subjects who take medicine and/or food for specified health use.
5. Subjects who took supplements and/or medicine for improvement of diabetes 1 month.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
Organization
Nitta Gelatin Inc.
Division name
R&D center
Zip code
581-0024
Address
Futamata 2-22, Yao city, Osaka, Japan
TEL
072-948-8252
se-koizumi@nitta-gelatin.co.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
Organization
Nitta Gelatin Inc.
Division name
R&D center
Zip code
581-0024
Address
Futamata 2-22, Yao city, Osaka, Japan
TEL
072-948-8252
Homepage URL
se-koizumi@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
Institute
Department
Personal name
Funding Source
Organization
Nitta Gelatin Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nitta Gelatin Ethics Review Committee
Address
Futamata 2-22, Yao city, Osaka, Japan
Tel
072-949-5386
hi-tanaka@nitta-gelatin.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 25 | 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
36
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 | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | 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 | 01 | Month | 08 | Day |
Last modified on
| 2019 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040434
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| Registered date | File name |
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