UMIN-CTR Clinical Trial

Basic information
Public title	The effect of substance X blended bread on postprandial blood glucose level in healthy human subjects.
Acronym	The effect of substance X blended bread on postprandial blood glucose level.
Scientific Title	The effect of substance X blended bread on postprandial blood glucose level in healthy human subjects.
Scientific Title:Acronym	The effect of substance X blended bread on postprandial blood glucose level.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of substance X blended bread on the postprandial blood glucose level elevation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose levels
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test bread (substance X blended), strawberry jam and black tea (single ingestion) -> Washout (not less than 1 week) -> Placebo bread (substance X non-blended), strawberry jam and black tea (single ingestion)
Interventions/Control_2	Placebo bread (substance X non-blended), strawberry jam and black tea (single ingestion) -> Washout (not less than 1 week) -> Test bread (substance X blended), strawberry jam and black tea (single ingestion)
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy volunteers. 2)Employees at the Hayashibara CO., LTD. 3)Subjects without any allergy symptoms related in the study. 4)Subjects who signed the informed consent for participation in the study.
Key exclusion criteria	1)Subjects with medical history of severe disorders. 2)Subjects with continuous medical treatment for chronic disease. 3)Pregnant or have possibility to become pregnant during the study or lactating women. 4)Subjects regularly using medicine, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) that may affect the results of the study. 5)Subjects work shifts. 6)Subjects who blood glucose levels are fasting < 60 mg/dL or >= 126 mg/dL, 120 minutes postprandial >= 189 mg/dL and random >= 270 mg/dL. (as the level of blood glucose from a capillary) 7)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Ishida
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	yuki.ishida@hb.nagase.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ishida
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	yuki.ishida@hb.nagase.co.jp

Sponsor
Institute	Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization	None
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
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	株式会社林原（岡山県） / Hayashibara CO., LTD. (Okayama)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 30 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	2017 Year 12 Month 01 Day
Date of IRB	2017 Year 12 Month 04 Day
Anticipated trial start date	2018 Year 01 Month 31 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 05 Month 23 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035449