UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052138 |
|---|---|
| Receipt number | R000059508 |
| Scientific Title | Observational study on the relationship between meal intake and postprandial blood glucose level |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/09/07 11:47:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study on the relationship between meal intake and postprandial blood glucose level
Acronym
Observational study on the relationship between meal intake and postprandial blood glucose level
Scientific Title
Observational study on the relationship between meal intake and postprandial blood glucose level
Scientific Title:Acronym
Observational study on the relationship between meal intake and postprandial blood glucose level
Region
| Japan |
Condition
Condition
borderline diabetics
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between meal intake and postprandial blood glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the postprandial blood glucose level
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female between 20 and 70 years of age.
2. Whoes BMI is between 18 and 30.
2. Borderline diabetics or fasting blood glucose level is 110 mg/dL to 125 mg/dL or HbA1c level is 6.0% to 6.4%
3. Subjects who are able to submit the written informed consents.
Key exclusion criteria
1. Subjects who consume probiotic foods or prebiotic foods during the study period
2. Subjects taking antibiotics
3. Subjects with a history of diabetes in the past
4. Subjects useing a cardiac pacemaker
5. Subjects with food allergies, or vegetarians
6. Subjects who cannot cook
7. Subjects execising hard or doing heavy physical labor during the study period
8. Subjects who undergo CT, MRT, and X-ray examinations during the study period
9. Subjects who will be underwater for more than 30 minutes during the study period
10. Subjects who cannot use measuring equipments
11. Subjects who have a history of drug dependence or alcohol dependence
12. Subjects in ohther clinical trial
13. Subjects who are pregnant, planning to become pregnant, or lactating
14. Subjects who are deemed to be unsuitable by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yoshimura |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Business Headquarter
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
050-1745-4018
makoto.yoshimura@glico.com
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Machida |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Business Headquarter
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka
TEL
080-8932-0881
Homepage URL
takayoshi.machida@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
050-1745-4027
toshihiko.koike@glico.com
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
| 2024 | Year | 03 | Month | 31 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
