UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036394 |
|---|---|
| Receipt number | R000041464 |
| Scientific Title | Safety evaluation of long-term ingestion of D-allulose in borderline diabates and type 2 diabetes. |
| Date of disclosure of the study information | 2019/04/03 |
| Last modified on | 2019/04/03 11:54:24 |
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Basic information
Public title
Safety evaluation of long-term ingestion of D-allulose in borderline diabates and type 2 diabetes.
Acronym
Safety evaluation of long-term ingestion of D-allulose in borderline diabates and type 2 diabetes.
Scientific Title
Safety evaluation of long-term ingestion of D-allulose in borderline diabates and type 2 diabetes.
Scientific Title:Acronym
Safety evaluation of long-term ingestion of D-allulose in borderline diabates and type 2 diabetes.
Region
| Japan |
Condition
Condition
Borderline diabetes, type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify safety of long-term ingestion of D-allulose
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence, types, magnitude and frequency of the adverse event(including clinical examinations)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 12 consecutive weeks
Interventions/Control_2
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Individuals who sign the consent document
2)Adult males and females aged 20-75 years
3)Individuals who satisfy inclusion criteria as below.
Borderline diabetes: Fasting blood glucose level is ranged from 110 mg/dL to 125 mg/dL
Diabetes: Type 2 diabetes under drug treatment
Key exclusion criteria
(1)daily intake of dietary supplement related to blood glucose
(2)serious damage to the liver, the renal, the heart, the lung, endocrine systems and metabolic functions
(3)currently taking medications excluding diabetes patients
(4)heavy user of alcohol and extremely random dietary habit
(5)allergy to foods and medicines
(6)abnormal values in the screening examination judged by the principal doctor
(7)pregnancy, breastfeeding, or expected / planned pregnancy
(8)participation in another clinical study
(9)blood donation within 12 weeks of the screening examination (> 400 mL) or 4weeks (> 200 mL), or directed donation within 2 weeks of the screening examination
(10)anyone judged as ineligible to participate in this study by the principal physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yamada |
Organization
Rare Sugar Foods LLC
Division name
Matsutani Chemical Industry Co., Ltd.
Zip code
763-0042
Address
307 Minatomachi Marugame-shi Kagawa Japan
TEL
072-771-2044
koji-yamada@matsutani.co.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Hayashi |
Organization
Rare Sugar Foods LLC
Division name
Matsutani Chemical Industry Co., Ltd.
Zip code
763-0042
Address
307 Minatomachi Marugame-shi Kagawa Japan
TEL
072-771-2044
Homepage URL
noriko-hayashi@matsutani.co.jp
Sponsor or person
Institute
Rare Sugar Foods LLC
Institute
Department
Personal name
Funding Source
Organization
None
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
Aiwa Clinic Reserch Ethics Committee
Address
1-590-1 Kawayanagicho Koshigaya-shi Saitama Japan
Tel
048-989-2000
taira@aiwacl.or.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 | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To submit a paper during preparation
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
| 2009 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2009 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 22 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041464
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
