UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037444 |
|---|---|
| Receipt number | R000042680 |
| Scientific Title | A study for an effect of the food containing plant-derived ingredient on blood glucose level (SME-2019-01-FOSHUS) |
| Date of disclosure of the study information | 2019/07/23 |
| Last modified on | 2020/11/05 10:21:37 |
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Basic information
Public title
A study for an effect of the food containing plant-derived ingredient on blood glucose level (SME-2019-01-FOSHUS)
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 (SME-2019-01-FOSHUS)
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
| Not applicable | 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 : Blood glucose level after carbohydrate tolerance test
Safety : Expression rate of side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Functional food, 12 weeks
Interventions/Control_2
Food without functional food, 12 weeks
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 male and female whose age are 20 <= years old <65.
(2)Subjects who are able to submit the written informed consents.
(3)Subjects who can visit the specified institution on the scheduled day of visit.
Key exclusion criteria
(1)Subjects who are with treatment.
(2)Subjects whose systolic pressure <90 mmHg.
(3)Females in pregnancy,lactation and scheduled pregnancy period.
(4)Subjects who donated over 200 mL blood components or whole blood within 4 weeks.
(5)Male subjects who donated over 400 mL whole blood within 12 weeks.
(6)Female who donated over 400 mL whole blood within 16 weeks.
(7)Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(8)Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(9)Subjects who are participating in other clinical studies,or who finished clinical study within 4 weeks.
(10)Subjects who are;
(a)With present heart disorder,liver disorder,or kidney disorder.
(b)With history of cardiac disorder.
(c)With diabetes mellitus.
(d)With allergy to drugs or foods.
(e)With glaucoma.
(f)With hyponatremia.
(11)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(12)Subjects who drink alcohol or smoke a lot.
(13)Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
(14)Subjects who experienced unpleasant feeling during drawing blood.
(15)Subjects who are deemed to be unsuitable by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Obata |
Organization
Suntory MONOZUKURI Expert Limited
Division name
R&D Support Department, HE Center
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL
03-5579-1277
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hoshiko |
Organization
Suntory MONOZUKURI Expert Limited
Division name
R&D Support Department, HE Center
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
0774-66-1110
Homepage URL
Hiroyuki_Hoshiko@suntory.co.jp
Sponsor or person
Institute
Suntory MONOZUKURI Expert Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2019 | Year | 07 | Month | 23 | 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
| 2019 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042680
