UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000016293
Receipt number	R000018902
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.
Date of disclosure of the study information	2015/01/21
Last modified on	2019/05/10 11:07:21

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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

Scientific Title:Acronym

Continuous intake study of partially abraded brown rice

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

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

Research contact person

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

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 or person

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

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018902

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name