UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044312 |
|---|---|
| Receipt number | R000050442 |
| Scientific Title | A study for the effect of modified rice starch on blood glucose. |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2022/10/06 10:24:24 |
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Basic information
Public title
A study for the effect of modified rice starch on blood glucose.
Acronym
A study for the effect of modified rice starch on blood glucose.
Scientific Title
A study for the effect of modified rice starch on blood glucose.
Scientific Title:Acronym
A study for the effect of modified rice starch on blood glucose.
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of modified rice starch (W, X, Y and Z) on blood glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic Index (GI)
Key secondary outcomes
1 Incremental area under the curve for blood glucose
2 Blood glucose
3 Questionnaires about test food (W, X, Y and Z) except glucose solution)
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
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
rice W, rice X, rice Y, rice Z, glucose solution
Interventions/Control_2
rice X, rice Y, rice Z, glucose solution, rice W
Interventions/Control_3
rice Y, rice Z, glucose solution, rice W, rice X
Interventions/Control_4
rice Z, glucose solution, rice W, rice X, rice Y
Interventions/Control_5
glucose solution, rice W, rice X, rice Y, rice Z
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
Key inclusion criteria
1 Japanese healthy men aged 20-50years
2 BMI between 20-25kg/m2
3 Individuals who can visit hospital on test days
4 Individuals whose written informed consent has been obtained.
Key exclusion criteria
1 Individuals who have allergic reaction to rice, wheat, egg, milk, beef, pork, chicken, soy, apple and gelatin
2 Individuals who have history of severe disorder and surgical disorder
3 Individuals who undergo treatment for cardiovascular, hepatic and kidney disorder including complication of other disorder in preliminary examination
4 Individuals suspected of infectious disorder from results of 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 within 70-109mg/dL
8 Individuals who have a more than 25% difference in the IAUC between the two preliminary examinations
9 Individuals diagnosed as impaired glucose tolerance in the past year
10 Individuals who donated whole blood or blood components exceeding 200 mL within 4 weeks, 400 mL whole blood within 4 months or, over 1200 mL whole blood within 12 months including blood samples to be taken in this study
11 Individuals participated in any other long term food consumption clinical study within 4 weeks or currently participate in any other clinical study
12 Individuals with excessive alcohol drinking (60 g or more per day in average) or smokers
13 Individuals with extremely irregular dietary lifestyle (including whose work time is between 10 p.m. to 5 a.m.)
14 Individuals currently taking medicine, health food product or a supplement that may affect blood glucose
15 Individuals who have experienced a feeling of unwellness or bad physical condition by blood drawing.
16 Individuals who need to avoid consuming food whose origin is not disclosed due to religious reasons or other
17 Individuals judged as inappropriate for the trial by the principal investigator with other reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Murakami |
Organization
Ajinomoto Co., Inc.
Division name
Food Products Division Institute of Food Sciences and Technologies Wellness Value Creation Center Functional Ingredients Development Group
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-210-5844
hitoshi_murakami@ajinomoto.com
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Shindo |
Organization
Ajinomoto Co., Inc.
Division name
Food Products Division Institute of Food Sciences and Technologies Wellness Value Creation Center Fu
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-210-5844
Homepage URL
daichi_shindo@ajinomoto.com
Sponsor or person
Institute
FUKUOKA KINEN PET KENSHIN CENTER
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, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Utsukushigaoka Hospital
Address
61-1 Shinei, Kiyota Ward, Sapporo, Hokkaido
Tel
011-882-0111
matsuda@ughp-cpc.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 | 05 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 27 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050442
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