UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042533 |
|---|---|
| Receipt number | R000048039 |
| Scientific Title | Glycemic and insulinemic response after oral ingestion of HBF2020-04 |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2021/04/14 11:45:48 |
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Basic information
Public title
Glycemic and insulinemic response after oral ingestion of HBF2020-04
Acronym
Glycemic and insulinemic response after oral ingestion of HBF2020-04
Scientific Title
Glycemic and insulinemic response after oral ingestion of HBF2020-04
Scientific Title:Acronym
Glycemic and insulinemic response after oral ingestion of HBF2020-04
Region
| Japan |
Condition
Condition
Healthy Japanease adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate Glycemic and insulinemic response after oral ingestion of HBF2020-04
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose and insulin level at 15, 30, 45, 60, 90, 120 min after ingestion
Key secondary outcomes
Physical examination, and medical examination by hematology, blood biochemistry, urinalysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test food HBF2020-04
Interventions/Control_2
Oral ingestion of glucose
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 and Female
Key inclusion criteria
[1] Healthy males and females aged 20-65 years old when informed consent.
[2]
[3] Individuals giving written informed consent
Key exclusion criteria
[1] Who have a disease and/or surgical history of serious hepatopathy, kidney damage, gastrointestinal disease, heart disease, peripheral vascular disorder, others which may affect the results of the study.
[2] Who with liver disorder, and/or kidney disorder.
[5] who are under medical treatments.
[6] Who are allergic to foods and/or medicines.
[7] Who are diagnosed as anemia.
[8] Who play intense sports and/or on a diet.
[10] Who use supplements which may affect the results of the study.
[11] Who take medicines.
[12] Who daily take excessive alcohol, and/or can't abstinent from alcohol from the day before the each examinations.
[13] Who are or are possibly pregnant, or who are lactating, during the study period.
[14] Who are participating or are willing to participate in other studies.
[15] Who are judged inappropriate for the study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Mizote |
Organization
Hayashibara CO., LTD.
Division name
R & D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
086-276-3141
akiko.mizote@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Mizote |
Organization
Hayashibara CO., LTD.
Division name
R & D Division, Development Unit
Zip code
7028006
Address
675-1, Fujisaki, Naka-ku, Okayama
TEL
086-276-3141
Homepage URL
akiko.mizote@hb.nagase.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Hayashibara 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
| 2020 | Year | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | 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 | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048039
