UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008370
Receipt number R000009840
Scientific Title Effects of brown rice or white rice on glycemic and lipid metabolism, and vascular function
Date of disclosure of the study information 2012/07/10
Last modified on 2018/01/09 14:07:20

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Basic information

Public title

Effects of brown rice or white rice on glycemic and lipid metabolism, and vascular function

Acronym

Effects of brown rice or white rice on vascular function

Scientific Title

Effects of brown rice or white rice on glycemic and lipid metabolism, and vascular function

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroshi Maegawa

Organization

Shiga University of Medical Science

Division name

Department of Medicine

Zip code


Address

Tsukinowa, Seta, Otsu, Shiga, Japan

TEL

077-548-2222

Email

maegawa@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keiko Kondo

Organization

Shiga University of Medical Science

Division name

Department of Public Health

Zip code


Address

Tsukinowa, Seta, Otsu, Shiga, Japan

TEL

077-548-2191

Homepage URL


Email

kon@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



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)



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

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


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

Main results already published

Date of protocol fixation

2011 Year 09 Month 20 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name