UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018022 |
|---|---|
| Receipt number | R000020879 |
| Scientific Title | Investigation for glycemic index and the subjective and objective indices for eating behavior of the high-amylose rice grown in Ehime prefecture: an one-arm trial. |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2023/11/16 21:57:12 |
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Basic information
Public title
Investigation for glycemic index and the subjective and objective indices for eating behavior of the high-amylose rice grown in Ehime prefecture: an one-arm trial.
Acronym
Investigation for glycemic index and the eating behavior-related indices of the high-amylose rice: an one-arm trial.
Scientific Title
Investigation for glycemic index and the subjective and objective indices for eating behavior of the high-amylose rice grown in Ehime prefecture: an one-arm trial.
Scientific Title:Acronym
Investigation for glycemic index and the eating behavior-related indices of the high-amylose rice: an one-arm trial.
Region
| Japan |
Condition
Condition
abnormal glucose tolerance
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
High-amylose rice may give extensive range of food choices for diabets patients. Therefore, objective of this study is to investigate glycemic index and the subjective and objective indices for eating behavior of the high-amylose rice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
glycemic index, insulin, appetite-related hormones
Key secondary outcomes
Subjective hunger and satiety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The 139g amylose-riched rice.
Interventions/Control_2
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person who agree with objective of this study, and write the informed consent form.
Key exclusion criteria
1. Body Mass Index<18.5 or >=30.
2. The persons who are currently treated hypertension, hyperlipidemia and diabetes, and have past history of digestive disease, cardiovascular diseases and cancer .
3. The other reasons for not to adapt to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Juntendo University
Division name
Department of Public Health
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1049
m_koutatsu_@hotmail.com
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Juntendo University
Division name
Department of Public Health
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1049
Homepage URL
m_koutatsu_@hotmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ehime Research Institute of Agriculture Forestry and Fisheries
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Hospital Ethics Review Board
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
chiken@juntendo.ac.jp
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
愛媛県農林水産研究所（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 12 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020879
