UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012644 |
|---|---|
| Receipt number | R000014786 |
| Scientific Title | Effect of partially abraded brawn rice, white rice and brown rice on postprandial glucose in Japanese healthy subjects and pre-diabetes subjects |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2014/06/20 09:24:04 |
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Basic information
Public title
Effect of partially abraded brawn rice, white rice and brown rice on postprandial glucose in Japanese healthy subjects and pre-diabetes subjects
Acronym
Single intake study of partially abraded brawn rice
Scientific Title
Effect of partially abraded brawn rice, white rice and brown rice on postprandial glucose in Japanese healthy subjects and pre-diabetes subjects
Scientific Title:Acronym
Single intake study of partially abraded brawn rice
Region
| Japan |
Condition
Condition
Healthy subjects
Pre-diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine glycemic index (GI) of partially abraded brawn rice compared with those of white rice and brown rice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
glycemic index (GI)
Key secondary outcomes
insulin, GLP-1, GIP, triglyceride
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
partially abraded brown rice
Interventions/Control_2
White rice
Interventions/Control_3
Brown rice
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Healthy subjects>
1) Aged 20 - 64 years
2) Capable of giving informed consent
<Pre-diabetes>
1) Aged 20 - 64 years
2) Fasting glucose not less than 100 mg/dL, under 126 mg/dL, or HbA1c not less than 5.7%, under 6.5%
3) Capable of giving informed consent
Key exclusion criteria
<Healthy subjects>
1) BMI over 25 kg/m2
2) Fasting glucose not less than 100 mg/dL
3) HbA1c not less than 5.7%
4) Triglyceride not less than 150mg/dL, HDL cholesterol less than 40mg/dL, LDL cholesterol not less than 140mg/dL
5) Subjects who is using medicines for treatment of chronic diseases
6) Current smokers
7) Subjects who are diagnosed anemia. Male; red blood cells less than 4.27 x 106/uL, hemoglobin less than 12.0g/dL, hematocrit less than 33.5%. Female; red blood cells less than 3.76 x 106/uL, hemoglobin less than 14.0g/dL, hematocrit less than 40.0%.
8) Subjects who were recognized unsuitable for this study by the Investigator.
<Pre-diabetes>
1) Subjects who are received pharmacotherapy for diabetes.
2) Current smokers
3) Subjects who are diagnosed anemia. Male; red blood cells less than 4.27 x 106/uL, hemoglobin less than 12.0g/dL, hematocrit less than 33.5%. Female; red blood cells less than 3.76 x 106/uL, hemoglobin less than 14.0g/dL, hematocrit less than 40.0%.
4) Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba
Faculty of Medicene
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address
1-1-1Tennodai, Tsukuba, Ibaraki
TEL
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba, Faculty of Medicene
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public
Zip code
Address
1-1-1Tennodai, Tsukuba, Ibaraki
TEL
029-853-3064
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Fuculty of Medicine
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization (NARO)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ibaraki Prefecture
Yamato Sangyo Co. Ltd
Faculty of Life and Environmental Scinences
National Food Research Institute
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | 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
| 2013 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 20 | Day |
Last modified on
| 2014 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014786
