UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055716 |
|---|---|
| Receipt number | R000063650 |
| Scientific Title | Glycemic index confirmation study of research foods |
| Date of disclosure of the study information | 2024/10/04 |
| Last modified on | 2024/10/03 10:26:02 |
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Basic information
Public title
Glycemic index confirmation study of research foods
Acronym
Glycemic index confirmation study of research foods
Scientific Title
Glycemic index confirmation study of research foods
Scientific Title:Acronym
Glycemic index confirmation study of research foods
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the potential for lowering the glycemic index (GI) of rice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic Index (GI) relative to rice
Glycemic Index (GI) relative to glucose solution
Key secondary outcomes
1.Incremental area under the curve for blood glucose
2.Maximum blood glucose level (Cmax, Measured blood glucose level) and amount of change from initial values
3.Time from start of feeding to maximum blood glucose level (Tmax)
4.Blood glucose level at each blood collection (actual value) and amount of change from initial value
5.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
Double blind -all involved 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/m^2
3.Individuals whose blood glucose IAUC difference is within 25% as a result of any two glucose tolerance tests with pre-test 1, 2 or 3 in some cases
4.Individuals who are in the habit of consuming three meals a day.
5.Individuals whose written informed consent has been obtained.
Key exclusion criteria
1.Individuals whose fasting glucose level are not within 70-109mg/dL
2.Individuals diagnosed as impaired glucose tolerance in the past year
3.Individuals with extremely irregular dietary lifestyle (Those who consume three meals a day but do not have the habit of eating between 7:00 a.m. and 8:00 p.m. as a rule of thumb.)
4.Individuals with irregular lifestyle(Shift work, late night work, etc.)
5.Individuals currently taking medicine, health food product or a supplement that may affect blood glucose
6.Individuals with excessive alcohol drinking(60 g or more per day in average)
7.Smokers(Including those who have been smoke-free for less than one year)
8.Individuals participated in any other long term food consumption clinical study within 4 weeks or currently participate in any other clinical study
9.Individuals who have allergic reaction to rice, drug or other food
10.Individuals with a history of serious medical or surgical problems
11.Individuals with medical conditions such as heart, liver, kidney, etc. under treatment(This includes if it is a complication of other diseases)
12.Individuals who have a current or medical history of gastrointestinal diseases or a history of gastrointestinal surgery with digestion and absorption problems(Gastric ulcer, peptic ulcer, etc.)
13.Individuals who have history of thyroid disorder
14.Individuals who have experienced a feeling of unwellness or bad physical condition by blood drawing.
15.Individuals suspected of infectious disorder
16.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
17.Individuals who need to avoid consuming food whose origin is not disclosed due to religious reasons or other
18.Individuals judged as inappropriate for the trial by the principal investigator with other reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Nishitani |
Organization
Ajinomoto Co., Inc.
Division name
Food Products Division, Institute of Food Sciences and Technologies, Wellness Value Creation Center, Functional Ingredients Group
Zip code
2108681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-1045-7701
shinobu.nishitani.vx8@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Hasumura |
Organization
Ajinomoto Co., Inc.
Division name
Food Products Division, Institute of Food Sciences and Technologies, Wellness Value Creation Center,
Zip code
2108681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
070-4325-5229
Homepage URL
mai.hasumura.hv6@asv.ajinomoto.com
Sponsor or person
Institute
CPCC Company Limited
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
Seishukai Clinic, Seishukai Medical corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
03-5827-0930
t-takahama@seishukai.or.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
医療法人社団 成守会 成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063650
