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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041195
Receipt No. R000047036
Scientific Title Study on the effect of food material on blood glucose
Date of disclosure of the study information 2021/01/01
Last modified on 2021/01/20

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Basic information
Public title Study on the effect of food material on blood glucose
Acronym Study on the effect of food material on blood glucose
Scientific Title Study on the effect of food material on blood glucose
Scientific Title:Acronym Study on the effect of food material on blood glucose
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of intake of food material for 7 days on the postprandial blood glucose in Japanese healthy males aged 20-64.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial blood glucose and insulin levels (at start and end of the test)
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 7 days (1 capsule/day)
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
65 years-old >
Gender Male
Key inclusion criteria 1)Males 20 to 65 years at the time of informed consent
2)Subjects who are healthy and have no chronic physical disease.
3)Subjects who are able to submit the written informed consents.
4)Subjects judged appropriate for the study by the principal.
Key exclusion criteria 1)Subjects who are with treatment.
2)With present heart disorder, liver disorder, or kidney disorder.
3)With previous or present cardiac disorder.
4)With diabetes mellitus.
5)Subjects who regularly use drugs, health foods, and supplements affecting the study
6)Heavy dinker
7)Subjects who have an extremely irregular diet habit (alternative worker, or work on midnight shift).
8)Subjects who experienced unpleasant feeling during drawing blood.
9)Subjects who have allergy related to the study foods
10)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code 110-0015
Address 6F Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo, Japan
TEL 03-6240-1162
Email info@ueno-asagao.clinc

Public contact
Name of contact person
1st name Susumu
Middle name
Last name Yoshino
Organization Maruzen Pharmaceuticals Co., Ltd.
Division name Research Center
Zip code 729-3102
Address 1089-8 Sagata, Shin-ichi, Fukuyama, Hiroshima, Japan
TEL 0847-52-5501
Homepage URL
Email s-yoshino@maruzenpcy.co.jp

Sponsor
Institute Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals Co., Ltd.
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 Ueno-Asagao Clinic Ethical Review Committee
Address 6F Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo, Japan
Tel 03-6240-1162
Email jimukyoku@tes-h.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
2021 Year 01 Month 01 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
2020 Year 07 Month 20 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2020 Year 07 Month 31 Day
Last follow-up date
2020 Year 08 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
2020 Year 07 Month 22 Day
Last modified on
2021 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047036

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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