UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049676 |
|---|---|
| Receipt number | R000056581 |
| Scientific Title | Confirmation test of increase in blood sugar level when drinking glico cafe ore |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2023/08/08 11:51:33 |
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Basic information
Public title
Confirmation test of increase in blood sugar level when drinking glico cafe ore
Acronym
Confirmation test of increase in blood sugar level when drinking glico cafe ore
Scientific Title
Confirmation test of increase in blood sugar level when drinking glico cafe ore
Scientific Title:Acronym
Confirmation test of increase in blood sugar level when drinking glico cafe ore
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of increase in blood sugar level when drinking glico cafe ore
Basic objectives2
Others
Basic objectives -Others
Confirmation of the inhibitory effect of milk on the rise in blood sugar level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose level when drinking glico cafe ore
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test drink:glico cafe ore
Intake period: 1 days
Daily intake: 180 ml
Interventions/Control_2
Test drink: Water in same amount of sugar
Intake period: 1 days
Daily intake: 180 ml
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1. Those who are currently undergoing drug treatment for some disease
2. Subjects with a history or current medical history of impaired glucose tolerance, mental illness, sleep disorder, hypertension, diabetes, hyperlipidemia, or other serious illness
3. Subjects with a fasting blood glucose level of 126 mg/dL or higher and HbA1c (NGSP) of 6.5% or higher
4. Those who have taken medication for the purpose of disease treatment in the past month (excluding headache, menstrual cramps, colds, etc.)
5. Those who have a history of serious disorders such as liver, kidney, heart, lungs, blood, etc
6.Those who have a history of comorbidities in the digestive system (excluding a history of cecum)
7. Subjects with a BMI of 30 kg/m2 or more
8. Those who have donated more than 200 mL of blood in the past month or more than 400 mL within 3 months
9. Subjects with severe anemia
10. Subjects who may have allergic symptoms to the test food, or subjects who may have serious allergic symptoms to other foods or medicines.
11. Subjects who have difficulty ingesting the entire load food and the test food (including palatability)
12. Those who are pregnant, breastfeeding, or may become pregnant
13. Subjects who regularly drink more than 40 g/day in terms of alcohol equivalent
14. Subjects who regularly drink more than 40 g/day in terms of aSubjects who may change their lifestyle during the test period (long-term travel, etc.)lcohol equivalent
15. Subjects who regularly drink more than 40 g/day in terms of aSubjects Subjects who currently or within the past 3 months have a habit of continuously ingesting foods with functional claims or health foods that claim to be related to sugar metabolism, or those who plan to ingest them during the test period (for the purpose of maintaining health) can be ingested)who may change their lifestyle during the test period (long-term travel, etc.)alcohol equivalent
16. Participating in a study that consumes other foods or uses drugs
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Morioka |
Organization
Ezaki Glico Co.ltd
Division name
Institute of Product and Technology Development
Zip code
555-8502
Address
4-6-5 Utashima, Nishiyodogawa-ku, Osaka city, Osaka prefecture
TEL
090-7871-8919
kensei.morioka@glico.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nakamura |
Organization
Ezaki Glico Co.ltd
Division name
Institute of Product and Technology Development
Zip code
555-8502
Address
Utashima, Nishiyodogawa-ku, Osaka city, Osaka prefecture
TEL
070-4015-4151
Homepage URL
yusuke.nakamura2@glico.com
Sponsor or person
Institute
Ezaki Glico Co.ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
2-4, Komatsubara-cho, Kita-ku, Osaka city, Osaka prefecture
Tel
+81-6-6477-8352
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 | 02 | Month | 01 | 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
| 2022 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056581
