UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052434 |
|---|---|
| Receipt number | R000059841 |
| Scientific Title | Study on postprandial blood glucose response test food intake in healthy subjects. |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/06 14:23:55 |
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Basic information
Public title
Study on postprandial blood glucose response test food intake in healthy subjects.
Acronym
Study on postprandial blood glucose response test food intake in healthy subjects.
Scientific Title
Study on postprandial blood glucose response test food intake in healthy subjects.
Scientific Title:Acronym
Study on postprandial blood glucose response test food intake in healthy subjects.
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of single dose of test foods on postprandial blood glucose in adult men aged 20 years or older less than 75 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose and insulin level
Key secondary outcomes
Blood triglyceride, GLP-1, and GIP level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo food (a single time intake) > 1 week washout > Test food (a single time intake)
Interventions/Control_2
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. Adult men between the ages of 20 and under 75
2. Subjects belonging to Kewpie Co. or medical institution who wish to voluntarily participate in clinical trials and obtain written consent.
3. Subjects who can maintain their daily habits during the test per
Key exclusion criteria
1. Are diagnosed with serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness.
2. Have a history of serious illness. (diabetes, heart disease, liver disease, kidney disease, cancer, etc.)
3. Have donated more than 200 mL of blood within one month or more than 400 mL of blood within three months before the start of the study.
4. Have experience of worsening physical condition due to blood sampling, or have been pointed out the blood sampling difficulty due to narrow blood vessels.
5. Have serious anemia
6. Have large changes in diet and exercise and cannot maintain their daily lifestyle.
7. Allergies to any medications or test foods
8. Taking foods or dietary supplements with functional health claims regularly
9. Unsuitable for the study, as determined by the investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kanemitsu |
Organization
Kewpie Corporation
Division name
Executive officer
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.
TEL
03-5384-7760
tomoyuki_kanemitsu@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative director
Zip code
103-0023
Address
516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo, Japan.
TEL
03-6225-5601
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2023 | Year | 10 | Month | 10 | 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
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059841
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
