UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to compare the effects of partially abraded brown rice , 70%-polished rice, and white rice on weight reduction: a randomized, parallel group, controlled trial.
Title of the study (Brief title)	Continuous intake study of partially abraded brown rice (2)
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of partially abraded brown rice, 70%-polished rice, and white rice on weight reduction, and glucose and lipid metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Body weight
Key secondary outcomes	1.Abdominal circumference 2.Visceral fat area 3.Blood pressure 4.Glucose metabolic indicator 5.Lipid metabolic indicator

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Partially abraded brown rice(12 weeks)
Interventions/Control_2	70%-polished rice(12 weeks)
Interventions/Control_3	White rice(12 weeks)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	1.Aged 40 - 70 years. 2.Body mass index not less than 25.0 kg/cm2, under 35.0 kg/cm2 3.Capable of giving informed consent
Key exclusion criteria	1.Fasting glucose not less than 126 mg/dL, or HbA1c not less than 6.5% 2.Subjects who are received pharmacotherapy for diabetes and dyslipidemia 3.No enrollment in another interventional study 4.Subjects who are received pharmacotherapy for alimentary disease 5.Pregnant or have the will to get pregnant women. 6.Lactating woman 7.Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size	150

Research contact person
Name of lead principal investigator	1) Koichi Hashimoto, 2) Toshiaki Hanafusa
Organization	1) University of Tsukuba, Faculty of Medicene 2) Osaka Medical College
Division name	1) Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation, 2) Department of Internal Medicine(1)
Address	1) 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan 2) 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	029-853-3064
Email	koichi.hashimoto@md.tsukuba.ac.jp

Public contact
Name of contact person	Koichi Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Clinical research and regional innovation donated by the JA Ibaraki Public Welfare Federation
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan 2. 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL	029-853-3064
Homepage URL
Email	koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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 5.Osaka Medical College Hospital 6.Mito Kyodo General Hospital
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	筑波大学附属病院（茨城県） 大阪医科大学附属病院（大阪府） 水戸協同病院（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 17 Day
Anticipated trial start date	2015 Year 07 Month 16 Day
Last follow-up date	2015 Year 12 Month 06 Day
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	2015 Year 06 Month 23 Day
Last modified on	2016 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000020894