UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034398 |
|---|---|
| Receipt number | R000039215 |
| Scientific Title | Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study- |
| Date of disclosure of the study information | 2018/10/09 |
| Last modified on | 2018/10/05 18:44:41 |
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Basic information
Public title
Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Acronym
Effect of test food on the postprandial blood glucose level
Scientific Title
Effect of test food on the postprandial blood glucose level -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym
Effect of test food on the 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 investigate the effect of test food on the postprandial blood glucose level of subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the curve (AUC) for postprandial blood glucose level
Key secondary outcomes
AUC for postprandial insulin level, and insulin levels and blood glucose levels at 30, 60, 90, and 120 minutes after rice ingestion
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food, and then intake of placebo after wash out period
Interventions/Control_2
Intake of placebo, and then intake of test food after wash out period
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 20 to 64 years of age
2)Subjects whose fasting blood glucose levels are less than 126 mg/dL
3)Subjects whose HbA1c(NGSP) are less than 6.5%
4)Subjects whose postprandial blood glucose levels at 30 or 60 minutes after 200g rice ingestion are more than 140 mg/dL
5)Subjects whose postprandial blood glucose levels at 120 minutes after 200g rice ingestion are less than 200 mg/dL
6)Subjects who consent to participate in the study, and can sign the consent form
Key exclusion criteria
1)Subjects who has serious medical history or who had digestive tract resection surgery
2)Subjects who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study
3)Subjects who have allergy to the test food or rice
4)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
5)Heavy use of alcohol or excessive smokers
6)Subjects who is considered to be inappropriate to attend the present study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Naito |
Organization
Kenkoin Medical corporation foundation
Division name
Kenkoin Clinic
Zip code
Address
6-7-4, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
医療法人財団健康院 健康院クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 12 | 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
| 2018 | Year | 10 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039215
| 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 |
