UMIN-CTR Clinical Trial

Public title

The study of improving glycometabolic effect for non-diabetic patients by eating glutinous brown rice in the medium term

Acronym

The effect of improving glycometabolism for non-diabetic patients by eating glutinous brown rice in the medium term

Scientific Title

The study of improving glycometabolic effect for non-diabetic patients by eating glutinous brown rice in the medium term

Scientific Title:Acronym

The effect of improving glycometabolism for non-diabetic patients by eating glutinous brown rice in the medium term

Region

Japan

Condition

non-diabetec patients

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of study was to discuss whether improving glycometabolic index of Japanese who are not diagnosed with diabetes by continuing to eat glutinous brown rice twice a day for 6 weeks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change of mean BMI and body fat mass

Key secondary outcomes

The change of plasma glucose, HbA1c, glycoalbumin, 1,5-AG, serum C-peptide, IRI, PI, LDL-C, HDL-C, and TG in fasting drawing blood

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food	Device,equipment

Interventions/Control_1

glutinous brown rice<GBR>
(eating for 6 weeks, twice a day, the amount of GBR per one meal which was based on the amount of individual stample food per one meal in everyday life)

Interventions/Control_2

white rice<WR> or white bread
(eating for 6 weeks, twice a day, the amount of WR or white bread per one meal which was based on the amount of individual stample food per one meal in everyday life)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

99

years-old

>=

Gender

Male and Female

Key inclusion criteria

Persons who received medical checkup / medical examination at Sagawa Town Ko-hoku National Health Insurance Hospital

Persons whose age is 20 years or older at the time of acquiring consent

Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding

Persons evaluated and judged appropriateby a managed nutritionist

Persons who intake white rice or white bread with regular meals

Key exclusion criteria

Persons undergoing diagnosis of diabetes

Persons using oral hypoglycemic agents, insulin, and antihyperlipidemic drugs

Persons undergoing dialysis

Women who are pregnant or may become pregnant, and lactating women

Persons whose intake of pure alcohol per day is 40 grum or more for men and 20 grum or more for females

Persons with diagnosis of dementia

Persons who recognized weight loss of 4 kg or more in the past 3 months

Persons who will travel for a long period during the examination period

Persons who use steroid formulation for a long time (internal or external use)

Eating snacks on a daily basis

Shift system workers

Persons who do not have a freezer at home (They can not keep glutinous brown rice)

Persons who ingest whole grain such as brown rice usually

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yasushi Tanaka

Organization

St. Marianna University School of Medicine

Division name

Metabolism and Endocrinology

Zip code

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture

TEL

044-977-8111

Email

y17tnk@marianna-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Taiga Nakayama

Organization

The Sakawa town Ko-hoku National Health Insurance Hospital

Division name

internal medicine

Zip code

Address

1687, Kou, Sakawa town, Takaoka-gun, Kouchi prefecture

TEL

0889-22-1166

Homepage URL

Email

t2nakayama@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

佐川町立高北国民健康保険病院

Date of disclosure of the study information

2017

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Non diabetes subjects increased 1,5-AG due to eating glutinous brown rice diet compared to Regular diet for 6 weeks.

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

08

Month

01

Day

Last follow-up date

2017

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

01

Day

Last modified on

2018

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032094