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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028028
Receipt No. R000032094
Scientific Title The study of improving glycometabolic effect for non-diabetic patients by eating glutinous brown rice in the medium term
Date of disclosure of the study information 2017/07/01
Last modified on 2018/07/16

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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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