UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037752 |
|---|---|
| Receipt number | R000043052 |
| Scientific Title | Effects of rice on blood glucose level : study 2 |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/02/20 13:52:13 |
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Basic information
Public title
Effects of rice on blood glucose level :
study 2
Acronym
Effects of rice on blood glucose level :
study 2
Scientific Title
Effects of rice on blood glucose level :
study 2
Scientific Title:Acronym
Effects of rice on blood glucose level :
study 2
Region
| Japan |
Condition
Condition
healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of rice on blood glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic Index (GI)
Key secondary outcomes
Incremental area under the blood glucose response curve (IAUC)
Peak of blood glucose level
Transition of blood glucose level
Questionnaires of test food
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
standard rice, rice a, rice f, rice e, rice d, rice c, rice b
Interventions/Control_2
standard rice, rice b, rice a, rice f, rice e, rice d, rice c
Interventions/Control_3
standard rice, rice c, rice b, rice a, rice f, rice e, rice d
Interventions/Control_4
standard rice, riced, rice c, ric eb, rice a, rice f, rice e
Interventions/Control_5
standard rice, rice e, riced, rice c, rice b, rice a, rice f
Interventions/Control_6
standard rice, rice f, rice e, rice d, rice c, rice b, rice a
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
Key inclusion criteria
1. Japanese healthy men aged 20-50years
2. BMI of 20-25 kg/m2
3. Individuals who can visit hospital on specified days
4. Individuals whose written informed consent has been obtained
Key exclusion criteria
1.Individuals who have allergic reaction to rice, wheat, barley, egg and milk
2.Individuals who have history of severe disorder and surgical disorder
3.Individuals who have medical disorder, cardiovascular, hepatic and kidney disorder, including complication of other disorder in preliminary examination
4.Individuals suspected of infectious disorder from results immunological examination
5.Individuals who have presence or previous history of gastrointestinal disease, or surgical history for excision of the gastrointestinal tract, gastric ulcer, peptic ulcer etc.
6.Individuals who have history of thyroid disorder
7.Individuals whose fasting glucose level are not 70-109 mg/dL
8.Individuals who have a difference within 25% in the IAUC of two preliminary examinations
9.Individuals diagnosed as impaired glucose tolerance in the past year
10.Individuals who donated blood (blood donation etc.) exceeding 200 mL within 4 weeks, 400 mL within 4 months or, 1200 mL within 12 months
11.Individuals participating in any other long clinical study involving human subjects within 4 weeks or currently participating in any other clinical study involving human subjects.
12.Individuals with excessive alcohol drinking or smokers
13.Individuals who can not eat regularly
14.Individuals currently intaking medicine, health food product or a supplement
15.Individuals who have experienced a feeling of unwellness or bad physical condition by blood drawing.
16.Individuals judged inappropriate for the trial by the principal
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Mine |
Organization
Ajinomoto Co., Inc.
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
2108681
Address
1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
tomoyuki_mine@ajinomoto.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Fujimura |
Organization
Ajinomoto Co., Inc.
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
2108681
Address
1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
Homepage URL
naoko_fujimura@ajinomoto.com
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinical Support Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital ethical review committee
Address
61-1, Shinei, Kiyota-ku, Sapporo-shi, Hokkaido
Tel
011-882-0111
info@csc-smo.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
医療法人 北武会 美しが丘病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043052
