UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041406
Receipt No. R000046666
Scientific Title Glycemic response after oral ingestion of HBF2020-01 and HBF2020-03
Date of disclosure of the study information 2020/08/13
Last modified on 2020/08/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Glycemic response after oral ingestion of HBF2020-01 and HBF2020-03
Acronym Glycemic response after oral ingestion of HBF2020-01 and HBF2020-03
Scientific Title Glycemic response after oral ingestion of HBF2020-01 and HBF2020-03
Scientific Title:Acronym Glycemic response after oral ingestion of HBF2020-01 and HBF2020-03
Region
Japan

Condition
Condition Healthy Japanease adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate Glycemic response after oral ingestion of HBF2020-01 and HBF-2020-03
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose level at 10, 20, 30, 40, 50, 60, 75, 90, 120 min after ingestion of HBF2020-01
Key secondary outcomes a

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test food HBF2020-01
Interventions/Control_2 Oral ingestion of glucose
Interventions/Control_3 Oral ingestion of the test food HBF2020-03
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 Japanease adults
2)Employees at the Hayashibara CO.,LTD.
3)Subjects who signed the informed consent for participation in the study
4)Individuals judged appropriate for the study by the principal investigator
Key exclusion criteria 1)Subjects with medical fistory of sever disorders
2)Pregnant or have possibility to become pregnant during the study or lactating women
3)Subjects who judged as unsuitable for this study by the principal investigator for any reasons
4) Subjects who may affect the result of the study due to the medications
5) Subjects who are judged to have loose stools on a daily basis
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
Email 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
Email akiko.mizote@hb.nagase.co.jp

Sponsor
Institute Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization non
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 The Ethics Committee of Hayashibara Co., Ltd.
Address 675-1, Fujisaki, Naka-ku, Okayama, Japan
Tel 086-276-3141
Email HB96301@hb.nagase.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
2020 Year 08 Month 13 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 20
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 No longer recruiting
Date of protocol fixation
2020 Year 07 Month 07 Day
Date of IRB
2020 Year 07 Month 17 Day
Anticipated trial start date
2020 Year 08 Month 07 Day
Last follow-up date
2020 Year 10 Month 01 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 08 Month 13 Day
Last modified on
2020 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.