UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of brown rice or white rice on glycemic and lipid metabolism, and vascular function
Title of the study (Brief title)	Effects of brown rice or white rice on vascular function
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of brown rice or white rice-based diet intervention on glycemic and lipid metabolism, and vascular function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Vascular function (both in fasting and in postprandial state) before and after intervention
Key secondary outcomes	Change in the following data during the intervention period 1) body weight, waist, blood pressure, body fat, abdominal visceral fat 2) IMT (Intima Media Thickness) 3) CAVI (Cardio Ankle Vascular Index) 4) AST, ALT, gamma-GTP, HbA1c, glycoalbumin, Total cholesterol, HDL cholesterol, LDL cholesterol, tPAI-1, hs-CRP, adiponectin, leptin, ADMA, lipid metabolites 5) mRNA expression of M1/M2 phenotype of PBM (TNF-alpha, MCP-1, CD11c, CD163, HO-1) 6) meal tolerance test (0, 30, 60, 90, 120min): glucose, insulin, triglyceride, free fatty acid, glucagon, GLP-1, GIP 7) Urine 8-isoprostane 8) bacterial flora 9) change in the eating behavior and psychosomatic state by questionnaire

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	YES
Institution consideration
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Brown rice group: 1) Brown rice period (2 months) Intake of brown rice as a staple food (2 times / day, 5 days / week). 2) Energy adjustment period (2 months) 3) Follow-up period (2 months)
Interventions/Control_2	White rice group: 1) White rice period (2 months) Intake of white rice as a staple food (2 times / day, 5 days / week). 2) Energy adjustment period (2 months) 3) Follow-up period (2 months)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) HbA1c < 8.0% (JDS) 2) Patients who don't use insulin therapy 3) Patients who don't take alpha-glycosidase inhibitor (alpha-GI) 4) no smoking
Key exclusion criteria	1) Patients with severe vascular, hepatic, renal, cancer, and/or infectious disease 2) Patients who changes drug treatment within 2 months 3) Patients with rapid weight loss 4) Patients who enrolled in another study within 1 month 5) Patients who have eaten brown rice 6) Patients who have taken fiber supplement 7) Pregnancy and breast-feeding patient 8) Patients who have taken warfarin
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Maegawa
Organization	Shiga University of Medical Science
Division name	Department of Medicine
Address	Tsukinowa, Seta, Otsu, Shiga, Japan
TEL	077-548-2222
Email	maegawa@belle.shiga-med.ac.jp

Public contact
Name of contact person	Keiko Kondo
Organization	Shiga University of Medical Science
Division name	Department of Public Health
Address	Tsukinowa, Seta, Otsu, Shiga, Japan
TEL	077-548-2191
Homepage URL
Email	kon@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Department of Medicine, Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sunstar Inc.
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	滋賀医科大学医学部附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 09 Month 20 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 06 Day
Last modified on	2018 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009840