UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brown Rice And Visceral fat obesity in Okinawa
Title of the study (Brief title)	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	Michio Shimabukuro, MD
Organization	Faculty of Medicine, University of the Ryukyus
Division name	Second Department of Internal Medicine
Address	207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL	09097854758
Email	mshimabukuro-ur@umin.ac.jp

Public contact
Name of contact person	Michio Shimabukuro
Organization	Tomishiro Chuo Hospital
Division name	Diabetes and Life-style related Disease Center
Address	25 Ueda, Tomigusuku City, Okinawa 901-0243, Japan
TEL	098-850-3811
Homepage URL
Email	hmoritake@yuuai.or.jp

Sponsor
Institute	Second Department of Internal Medicine, University of the Ryukyus and Diabetes and Life-style related Disease Center, Tomishiro Chuo Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001861