UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043040 |
|---|---|
| Receipt number | R000049082 |
| Scientific Title | Evaluation of a bifunctional effect of cooked rice on prevention of diabetes mellitus and cognition disorder. |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/12/13 15:52:38 |
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Basic information
Public title
Evaluation of a bifunctional effect of cooked rice on prevention of diabetes mellitus and cognition disorder.
Acronym
Evaluation of a bifunctional effect of cooked rice on prevention of diabetes mellitus and cognition disorder.
Scientific Title
Evaluation of a bifunctional effect of cooked rice on prevention of diabetes mellitus and cognition disorder.
Scientific Title:Acronym
Evaluation of a bifunctional effect of cooked rice on prevention of diabetes mellitus and cognition disorder.
Region
| Japan |
Condition
Condition
Healthy human
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of changes in postprandial blood glucose and insulin levels in test and control foods, along with their IAUCg and IAUCi.
Evaluate anti-dementia effect by measuring amyloid-beta before and after ingestion of test and control food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose levels, insulin levels
Key secondary outcomes
IAUCg, IAUCi, amyloid-beta
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 177g of test food and 310ml of water. > Washout > ingest 135g control food and 310ml of water.
Interventions/Control_2
Ingest 135g of control food and 310ml of water. > Washout > ingest 177g test food and 310ml of water.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Fasting plasma glucose = <126mg/dL.
2.Individual having screening test result and questionnaire result judged to be appropriate for this study by investigator.
Key exclusion criteria
1. Diabetes mellitus under medical treatment.
2. Individual having severe diseases (e.g. liver, kidney, heart, blood diseases, and infections requiring the notification)
3. Individual received gastrectomy, enterectomy, and gastro-intestinal diseases, judged to be inappropriate for this study.
4. Pregnant, women having the possibility, and lactating women.
5. Participants in order clinical trial.
6. Individual rejected participating in this study by chief investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata Bio-Research Park, Inc
Division name
Advisor
Zip code
9560841
Address
316-2, Higashijima, Akiha-ku, Niigata, Japan
TEL
0250251196
wataken@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Goto |
Organization
Niigata Bio-Research Park, Inc
Division name
Business promotion division
Zip code
9560841
Address
316-2 Higashijima, Akiha-ku, Niigata, Japan
TEL
0250-25-1196
Homepage URL
goto@nbrp.co.jp
Sponsor or person
Institute
Niigata Bio-Research Park, Inc
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Pharmacy and Applied Life Sciences
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
NBRC Research Ethics Review Committee
Address
316-2, Higashijima, Akiha-uk, Niigata, 956-0841, Japan
Tel
0250251196
nbrp-food-navi@nbrp.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 04 | 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
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049082
