UMIN-CTR Clinical Trial

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
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	Oneness Support Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048039