UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015252 |
|---|---|
| Receipt number | R000017727 |
| Scientific Title | The of effects of newly developed long-chain amylopectin-containing-rice,Konayukinomai,and its processed products on postprandial glucose level.Long-team trial |
| Date of disclosure of the study information | 2014/09/25 |
| Last modified on | 2016/06/21 09:57:33 |
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Basic information
Public title
The of effects of newly developed long-chain amylopectin-containing-rice,Konayukinomai,and its processed products on postprandial glucose level.Long-team trial
Acronym
Long-team trial on the developed long-chain amylopectin-containing-rice
Scientific Title
The of effects of newly developed long-chain amylopectin-containing-rice,Konayukinomai,and its processed products on postprandial glucose level.Long-team trial
Scientific Title:Acronym
Long-team trial on the developed long-chain amylopectin-containing-rice
Region
| Japan |
Condition
Condition
Metabolic Syndrome
Initial Diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term (3months) consumption of newly developed long-chain amylopectin-contain-rice,Konayukinomai,on glucose and insulin resistance was investigated in 60men
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level of the day
Visceral fat area
Key secondary outcomes
HbA1c,insuline,food intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Konayukinomai as a steam rice per 200g once a day for 3 months
Interventions/Control_2
Kosihikari as a steam rice per 200g once a day for 3 months
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Viceral fat area<100cm2
HbA1c<8.0%
Key exclusion criteria
Exsist hepatic failure or renal disease
Food Allergy
The person who was disqualified by a docotor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tanaka |
Organization
kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome Toshima-ku, Tokyo
TEL
03-3918-6181
atanaka@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome Tosimaku, Tokyo
TEL
03-3918-6181
Homepage URL
kamachi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutriton University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 25 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017727
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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