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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | non-diabetec patients | |
Classification by specialty |
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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 |
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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) |
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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) |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |