UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016293 |
|---|---|
| Receipt number | R000018902 |
| Scientific Title | A study to compare the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes: a randomized, parallel group, controlled trial. |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2019/05/10 11:07:21 |
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Basic information
Public title
A study to compare the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes: a randomized, parallel group, controlled trial.
Acronym
Continuous intake study of partially abraded brown rice
Scientific Title
A study to compare the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes: a randomized, parallel group, controlled trial.
Scientific Title:Acronym
Continuous intake study of partially abraded brown rice
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight
Key secondary outcomes
1.Abdominal circumference
2.Percent of body fat
3.Blood pressure
4.Glucose metabolic indicator
5.Lipid metabolic indicator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Partially abraded brown rice(12 weeks)
Interventions/Control_2
White rice(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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Aged 40 - 64 years.
2.Body mass index not less than 25 kg/cm2, under 30 kg/cm2
3.Fasting glucose not less than 100 mg/dL, under 126 mg/dL, or HbA1c not less than 5.7%, under 6.5%.
4.Capable of giving informed consent
Key exclusion criteria
1.Subjects who are received pharmacotherapy for diabetes and dyslipidemia.
2.No enrollment in another interventional study
3.Current smokers.
4.Subjects who are received pharmacotherapy for alimentary disease
5.Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size
60
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
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
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
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
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
1.Ibaraki Prefecture
2.Yamato Sangyo Co. Ltd
3.Department of Internal Medicine
4.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.clnesp.2017.01.015
Number of participants that the trial has enrolled
41
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
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | 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
| 2015 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018902
