UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035648 |
|---|---|
| Receipt number | R000040608 |
| Scientific Title | A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY) |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2019/08/05 15:11:49 |
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Basic information
Public title
A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY)
Acronym
A study for an effect of the food containing plant-derived ingredient on blood glucose level
Scientific Title
A study for an effect of the food containing plant-derived ingredient on blood glucose level(SBF-2018-05-SMLIY)
Scientific Title:Acronym
A study for an effect of the food containing plant-derived ingredient on blood glucose level
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an effect of the food containing plant-derived ingredient on blood glucose level
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy : Area under the curve of blood glucose level, fasting blood glucose
Safety : Incidence of adverse effects
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day.
Interventions/Control_2
Subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (2) once a day.
Interventions/Control_3
Subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day.
Interventions/Control_4
Subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (1) once a day.
Interventions/Control_5
Subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (1) once a day. After more than 5 days of washout period, subjects will take the food (2) once a day.
Interventions/Control_6
Subjects will take the placebo food once a day. After more than 5 days of washout period, subjects will take the food (2) once a day. After more than 5 days of washout period, subjects will take the food (1) once a day.
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 male and female whose age are 20 <= years old <65.
(2)Subjects who are able to submit the written informed consents.
Key exclusion criteria
(1)Females in pregnancy, lactation and scheduled pregnancy period.
(2)Subjects who are attending other studies or attended other studies within past 4 weeks.
(3)With present heart disorder, liver disorder, or kidney disorder
(4)With previous or present cardiac disorder
(5)With diabetes mellitus, or
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Teramoto |
Organization
Suntory Beverage & Food Limited
Division name
Development and Design Department
Zip code
Address
13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL
050-3182-6114
Takanori_Teramoto@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Matsuoka |
Organization
Suntory Beverage & Food Limited
Division name
Development and Design Department
Zip code
Address
13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL
050-3182-0550
Homepage URL
Kaori_Matsuoka@suntory.co.jp
Sponsor or person
Institute
Suntory Beverage & Food Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
Address
Tel
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
| 2019 | Year | 01 | Month | 24 | 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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040608
