UMIN-CTR Clinical Trial

Basic information
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
Condition	non-diabetec patients
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	佐川町立高北国民健康保険病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2017 Year 07 Month 01 Day
Last modified on	2018 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032094

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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