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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018037
Receipt No. R000020894
Scientific Title 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.
Date of disclosure of the study information 2015/07/16
Last modified on 2016/04/06

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Basic information
Public title 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.
Acronym Continuous intake study of partially abraded brown rice (2)
Scientific Title 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.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name 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)
Zip code
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
1st name
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Faculty of Medicene
Division name Clinical research and regional innovation donated by the JA Ibaraki Public Welfare Federation
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

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
2015 Year 06 Month 17 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000020894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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