UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022464 |
|---|---|
| Receipt number | R000025886 |
| Scientific Title | Effect of food containing plant-derived ingredient on postprandial blood glucose level-placebo-control,double-blind labeled,crossover trial |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2016/09/02 12:19:59 |
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Basic information
Public title
Effect of food containing plant-derived ingredient on postprandial blood glucose level-placebo-control,double-blind labeled,crossover trial
Acronym
Effect of food containing plant-derived ingredient on postprandial blood glucose level
Scientific Title
Effect of food containing plant-derived ingredient on postprandial blood glucose level-placebo-control,double-blind labeled,crossover trial
Scientific Title:Acronym
Effect of food containing plant-derived ingredient on postprandial blood glucose level
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore inhibitory effect of food containing plant-derived ingredient on postprandial blood glucose level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose level after meal until 120 minutes later
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will take the food containing plant-derived ingredient once a day. After more than 5 days of washout period, subjects will take the food containing no plant-derived ingredient once aday
Interventions/Control_2
Subjects will take the food containing no plant-derived ingredient once aday. After more than 5 days of washout period, subjects will take the food containing plant-derived ingredient once aday
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) Males and females from 20 to 65 years of age
2) Subjects falling under any of the following
A. fasting blood glucose levels are ranged 110 to 125 mg/dL
B. 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL
3) Understanding the study and submitting the written informed consent before the study
Key exclusion criteria
1) With diabetes mellitus or glucose metabolism disorder
2) Females in pregnancy,lactation and scheduled pregnancy period
3) With heart disorder liver disorder,and kidney disorder
4) With previous or present cardiac disorder
5) With allergy to drugs or foods
6) Use of product affecting the data of this study,such as medicine,food for specified health use,food with function claims,supplement,diet food
7) Investigator's judgment for other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Nakamura |
Organization
Suntory Business Expert Limited
Division name
HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL
03-5579-1277
Junichi_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Matsuoka |
Organization
Suntory Business Expert Limited
Division name
HE Center
Zip code
Address
2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL
03-5579-1277
Homepage URL
Kaori_Matsuoka@suntory.co.jp
Sponsor or person
Institute
Suntory Business 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
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
| 2016 | Year | 05 | Month | 27 | 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
| 2016 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
