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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035487
Receipt No. 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 2019/01/30

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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
Middle name
Last name Seiko Koizumi
Organization Nitta Gelatin Inc.
Division name R&D center
Zip code
Address Futamata 2-22, Yao city, Osaka, Japan
TEL 072-948-8252
Email se-koizumi@nitta-gelatin.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiko Koizumi
Organization Nitta Gelatin Inc.
Division name R&D center
Zip code
Address Futamata 2-22, Yao city, Osaka, Japan
TEL 072-948-8252
Homepage URL
Email se-koizumi@nitta-gelatin.co.jp

Sponsor
Institute Nitta Gelatin Inc.
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 22 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
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040434

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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