UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041195 |
|---|---|
| Receipt number | 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 17:16:50 |
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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
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
s-yoshino@maruzenpcy.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047036
| 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 |
