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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036394
Receipt No. 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

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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
Email 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
Email noriko-hayashi@matsutani.co.jp

Sponsor
Institute Rare Sugar Foods LLC
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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