UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009989 |
|---|---|
| Receipt number | R000001861 |
| Scientific Title | Brown Rice And Visceral fat obesity in Okinawa |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2018/08/13 09:19:04 |
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Basic information
Public title
Brown Rice And Visceral fat obesity in Okinawa
Acronym
Brown Rice And Visceral fat obesity in Okinawa (BRAVO)
Scientific Title
Brown Rice And Visceral fat obesity in Okinawa
Scientific Title:Acronym
Brown Rice And Visceral fat obesity in Okinawa (BRAVO)
Region
| Japan |
Condition
Condition
Subjects who have visceral fat obesity with impaired glucose tolerance and type 2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study effects of brown rice on abdominal fat mass, metabolic parameters, and vascular function in subjects who have visceral fat obesity with impaired glucose tolerance and type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma levels of glucose, insulin, lipids and adipocytokine and endothelial function before and after ingestion of white rice or brown rice
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Encouraged to take white rice for 12 weeks
Interventions/Control_2
Encouraged to take brown rice for 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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who have abdominal fat obesity with impaired glucose tolerance or type 2 diabetes mellitus
Key exclusion criteria
1. Subjects who undertake medication to influence on study results
2. Subjects who have diabetic complications
3. Subjects who have infectious diseases or history of recent operation and injury
4. Expected, pregnant or nursing women
5. Subjects who have renal, liver or other organ dysfunction
6. Subjects who have history of abdominal operation or bowel obstruction
7. Subjects who have chronic bowel diseases with digestion and absorption disorders
8. Subjects to be inappropriate as an object of this examination by other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro, MD |
Organization
Faculty of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL
09097854758
mshimabukuro-ur@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
Tomishiro Chuo Hospital
Division name
Diabetes and Life-style related Disease Center
Zip code
Address
25 Ueda, Tomigusuku City, Okinawa 901-0243, Japan
TEL
098-850-3811
Homepage URL
hmoritake@yuuai.or.jp
Sponsor or person
Institute
Second Department of Internal Medicine, University of the Ryukyus and Diabetes and Life-style related Disease Center, Tomishiro Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research, Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
豊見城中央病院 生活習慣病センター（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001861
| 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 |
