UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059003 |
|---|---|
| Receipt number | R000066954 |
| Scientific Title | Evaluation of the Effect of the Test Beverage on GLP-1 Secretion |
| Date of disclosure of the study information | 2026/09/05 |
| Last modified on | 2026/04/28 17:24:09 |
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Basic information
Public title
Evaluation of the Effect of the Test Beverage on GLP-1 Secretion
Acronym
Evaluation of the Effect of the Test Beverage on GLP-1 Secretion
Scientific Title
Evaluation of the Effect of the Test Beverage on GLP-1 Secretion
Scientific Title:Acronym
Evaluation of the Effect of the Test Beverage on GLP-1 Secretion
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a single intake of the test beverage on circulating GLP-1 secretion, and its effects on blood glucose, insulin, and subjective visual analogue scale (VAS) ratings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Active GLP-1
Key secondary outcomes
Blood glucose (GLU)
Insulin (IRI)
Subjective VAS ratings
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single oral administration of Test Beverage 1
Interventions/Control_2
A single oral administration of Test Beverage 2
Interventions/Control_3
A single oral administration of Test Beverage 3
Interventions/Control_4
A single oral administration of Test Beverage 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals who are able to undergo serial blood sampling.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals with HbA1c greater than or equal to 6.5%.
2. Individuals with a blood glucose level at 2 hours greater than or equal to 200 mg/dL during the pre-screening oral glucose tolerance test.
3. Individuals with a fasting blood glucose level greater than or equal to 126 mg/dL.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims related to blood glucose which could affect the study, and who are unable to discontinue use from the time of consent acquisition.
5. Individuals who are taking medications that could affect the study, such as intestinal regulators or laxatives.
6. Individuals who have used for medications for disease treatment (excluding occasional use for headache, menstrual pain, common cold, etc.) within 1 month prior to consent acquisition.
7. Individuals use of any antibiotic-containing medications from 1 month prior to informed consent until the time of consent acquisition.
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with excessive alcohol intake.
10. Individuals on intentional dietary restriction.
11. Individuals with irregular lifestyle or eating habits (for example, shift work, night work), or those likely to have lifestyle changes during the study period
12. Individuals who have experienced a marked change in living environment affecting lifestyle within 1 month prior to informed consent (for example, moving residence, unemployment, divorce, death of a spouse or relative).
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality and Innovations,Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2026 | Year | 09 | Month | 05 | 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
| 2025 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
13. Individuals who have a history of or a current diagnosis of neurological or psychiatric disorders, rheumatoid arthritis, sleep disorders, hypertension, diabetes mellitus, dyslipidemia, gastrointestinal disorders, endocrine disorders, eating disorders, drug dependence, or other serious illnesses.
14. Individuals who have a history of or a current diagnosis of serious diseases of the heart, liver, kidneys, lungs, gastrointestinal tract, or blood.
15. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period.
16. Individuals with allergies to medications and/or food.
17. Individuals who donated 200 mL of their blood or blood components within the last month.
18. Individuals who donated 400 mL of his blood within the last 3 months.
19. Individuals who donated 400 mL of her blood within the last 4 months.
20. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
21. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
22. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066954
