UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031038 |
|---|---|
| Receipt number | R000035449 |
| Scientific Title | The effect of substance X blended bread on postprandial blood glucose level in healthy human subjects. |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2020/01/31 16:10:07 |
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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
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
yuki.ishida@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035449
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