UMIN-CTR Clinical Trial

Basic information
Public title	A study to compare the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes: a randomized, parallel group, controlled trial.
Acronym	Continuous intake study of partially abraded brown rice
Scientific Title	A study to compare the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes: a randomized, parallel group, controlled trial.
Scientific Title:Acronym	Continuous intake study of partially abraded brown rice
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of partially abraded brown rice and white rice on degree of obesity, glucose and lipid metabolism of subjects with pre-diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Body weight
Key secondary outcomes	1.Abdominal circumference 2.Percent of body fat 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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Partially abraded brown rice(12 weeks)
Interventions/Control_2	White rice(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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Aged 40 - 64 years. 2.Body mass index not less than 25 kg/cm2, under 30 kg/cm2 3.Fasting glucose not less than 100 mg/dL, under 126 mg/dL, or HbA1c not less than 5.7%, under 6.5%. 4.Capable of giving informed consent
Key exclusion criteria	1.Subjects who are received pharmacotherapy for diabetes and dyslipidemia. 2.No enrollment in another interventional study 3.Current smokers. 4.Subjects who are received pharmacotherapy for alimentary disease 5.Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Koichi Hashimoto
Organization	University of Tsukuba Faculty of Medicene
Division name	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3064
Email	koichi.hashimoto@md.tsukuba.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Koichi Hashimoto
Organization	University of Tsukuba
Division name	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, 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
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

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.clnesp.2017.01.015
Number of participants that the trial has enrolled	41
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 01 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 21 Day
Last modified on	2019 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018902