UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028028 |
|---|---|
| Receipt number | 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 21:25:36 |
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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
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
t2nakayama@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032094
