UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040410 |
|---|---|
| Receipt number | R000045726 |
| Scientific Title | Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise |
| Date of disclosure of the study information | 2020/05/15 |
| Last modified on | 2020/11/16 12:39:25 |
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Basic information
Public title
Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Acronym
Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Scientific Title
Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Scientific Title:Acronym
Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is an exploratory study aimed at verifying whether the intake of brown rice crackers with enhanced dietary fiber can be expected to have a higher blood sugar suppression effect than the intake of ordinary white rice crackers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Since this study is an exploratory study of "whether brown rice crackers reinforced with dietary fiber suppress an increase in blood sugar levels", only the blood sugar level using a simple blood glucose meter is used as an evaluation item. Blood glucose is measured by fingertip puncture with a simple blood glucose meter before, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes after ingestion.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A group that consumes brown rice crackers with enhanced dietary fiber.
Ingest a single 100g test meal within 10 minutes.
Interventions/Control_2
A group that consumes regular white rice crackers.
Ingest a single 100g test meal within 10 minutes.
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
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Fasting blood glucose level is less than 126 mg / dL
(2) Those who have determined that the researcher can participate in the research safely
Key exclusion criteria
(1) Those who are receiving treatment or medication for diabetes
(2) Those who have severe cerebrovascular disease, heart disease, renal disease, digestive disease
(3) Patients with a large history of gastrointestinal surgery, such as gastrectomy, gastrointestinal suture, or gastrointestinal resection
(4) Participants who are currently participating in other clinical research or have been participating within one month
(5) Others who are judged to be inappropriate for the research subject
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirohiro |
| Middle name | |
| Last name | Sone |
Organization
Niigata University Faculty of Medicine
Division name
Department of Hematology, Endocrinology and Metabolism
Zip code
9518510
Address
1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
TEL
0253689026
sone@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Niigata University Faculty of Medicine
Division name
Department of Hematology, Endocrinology and Metabolism
Zip code
9518510
Address
1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
TEL
0253689302
Homepage URL
hiroshi-suzuki@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Faculty of Medicine
Department of Hematology, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Niigata University Faculty of Medicine
Department of Hematology, Endocrinology and Metabolism
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
Research Ethics Review Committee for Niigata University
Address
1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
Tel
0252236161
ethics@adm.niigata-u.ac.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
| 2020 | Year | 05 | Month | 15 | 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
9
Results
A crossover study was conducted in which subjects ingested fiber-enriched white rice crackers and brown rice crackers. 60 and 120 minutes after ingesting fiber-enriched brown rice crackers, the rise in blood glucose was suppressed that compared to when you ingested white rice crackers.
Results date posted
| 2020 | Year | 11 | Month | 16 | Day |
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
| 2020 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045726
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