UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057113 |
|---|---|
| Receipt number | R000065270 |
| Scientific Title | Study on the effect of mayonnaise on postprandial blood glucose after Rice Consumption |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/08/22 09:36:11 |
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Basic information
Public title
Study on the effect of mayonnaise on postprandial blood glucose after Rice Consumption
Acronym
Study on the effect of mayonnaise on postprandial blood glucose after Rice Consumption
Scientific Title
Study on the effect of mayonnaise on postprandial blood glucose after Rice Consumption
Scientific Title:Acronym
Study on the effect of mayonnaise on postprandial blood glucose after Rice Consumption
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare postprandial blood glucose levels after consuming rice with/without mayonnaise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Blood insulin, incretin, and free fatty acid levels
Glucose level in the interstitial fluid by continuous glucose monitoring (for those who wish)
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
Single ingestion of placebo food (rice) > Washout period > Single ingestion of test food (rice with oil) (optional) > Washout period > single ingestion of test food (rice with mayonnaise)
Interventions/Control_2
150 g of rice and 15 g of mayonnaise
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
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy males aged 20 years or older but under 75 years.
2) Individuals who voluntarily wish to participate in the clinical trial and can provide written informed consent.
3) Individuals who can maintain a consistent daily lifestyle during the study period.
Key exclusion criteria
1) Individuals with severe diseases (e.g., diabetes, heart disease, liver disease, kidney disease, cancer) or mental disorders.
2) Individuals with a history of severe diseases (e.g., diabetes, heart disease, liver disease, kidney disease, cancer).
3) Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL within the past three months.
4) Individuals who have experienced discomfort or health deterioration due to blood sampling in the past, or those who have been told that blood sampling is difficult due to thin veins.
5) Individuals with severe anemia.
6) Individuals with significant fluctuations in diet and exercise habits who cannot maintain a consistent daily lifestyle.
7) Individuals who may have food allergies related to the test food.
8) Individuals who regularly consume food for specified health uses or dietary supplements.
9) Any other individuals deemed ineligible for participation by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Chairperson
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
173-0004
Address
2-63-9-401, Itabashi, Itabashi-ku, Tokyo, JAPAN
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
CXwellness Inc.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
wnb@cto-net.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
| 2025 | Year | 02 | Month | 28 | 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
| 2024 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | 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
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065270
