UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061354 |
|---|---|
| Receipt number | R000069496 |
| Scientific Title | A Study on the Secretory Dynamics of GLP-1 Following Beverage Consumption |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/04/22 19:12:21 |
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Basic information
Public title
A Study on the Secretory Dynamics of GLP-1 Following Beverage Consumption
Acronym
A Study on the Secretory Dynamics of GLP-1 Following Beverage Consumption
Scientific Title
A Study on the Secretory Dynamics of GLP-1 Following Beverage Consumption
Scientific Title:Acronym
A Study on the Secretory Dynamics of GLP-1 Following Beverage Consumption
Region
| Japan |
Condition
Condition
Volunteer
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in blood GLP-1 concentration following consumption of functional beverages (matcha beverage, flavonoid-containing beverage, whey protein beverage, green tea catechin beverage, indigestible dextrin-containing beverage).
Basic objectives2
Others
Basic objectives -Others
GLP-1 (glucagon-like peptide-1) is an incretin hormone secreted from the small intestine. It plays a crucial role in blood glucose control by promoting insulin secretion in a glucose-dependent manner and suppressing glucagon secretion. Furthermore, due to its effects of delaying gastric emptying and suppressing appetite, it is attracting attention in diabetes treatment and obesity countermeasures. Recent animal and cell culture studies have demonstrated that various food components influence GLP-1 secretion. Specifically, catechins in green tea, flavonoids in citrus fruits, and whey protein have been suggested to promote GLP-1 secretion.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
iAUC 0-120 min of GLP-1 concentration after each beverage intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
This study evaluates GLP-1 secretion dynamics after consuming five types of functional beverages in healthy adults.
Each subject will consume the five beverages on separate days, with changes in hormone dynamics (including GLP-1) and blood glucose levels observed before and after consumption. No randomization will be performed; all subjects will consume the five beverages in the same order (Visit 1: Beverage A, Visit 2: Beverage B, Visit 3: Beverage C, Visit 4: Beverage D, Visit 5: Beverage E).
Interventions/Control_2
This study evaluates GLP-1 secretion dynamics after consuming five types of functional beverages in healthy adults.
Each subject will consume the five beverages on separate days, with changes in hormone dynamics (including GLP-1) and blood glucose levels observed before and after consumption. No randomization will be performed; all subjects will consume the five beverages in the same order (Visit 1: Beverage A, Visit 2: Beverage B, Visit 3: Beverage C, Visit 4: Beverage D, Visit 5: Beverage E).
Interventions/Control_3
This study evaluates GLP-1 secretion dynamics after consuming five types of functional beverages in healthy adults.
Each subject will consume the five beverages on separate days, with changes in hormone dynamics (including GLP-1) and blood glucose levels observed before and after consumption. No randomization will be performed; all subjects will consume the five beverages in the same order (Visit 1: Beverage A, Visit 2: Beverage B, Visit 3: Beverage C, Visit 4: Beverage D, Visit 5: Beverage E).
Interventions/Control_4
This study evaluates GLP-1 secretion dynamics after consuming five types of functional beverages in healthy adults.
Each subject will consume the five beverages on separate days, with changes in hormone dynamics (including GLP-1) and blood glucose levels observed before and after consumption. No randomization will be performed; all subjects will consume the five beverages in the same order (Visit 1: Beverage A, Visit 2: Beverage B, Visit 3: Beverage C, Visit 4: Beverage D, Visit 5: Beverage E).
Interventions/Control_5
This study evaluates GLP-1 secretion dynamics after consuming five types of functional beverages in healthy adults.
Each subject will consume the five beverages on separate days, with changes in hormone dynamics (including GLP-1) and blood glucose levels observed before and after consumption. No randomization will be performed; all subjects will consume the five beverages in the same order (Visit 1: Beverage A, Visit 2: Beverage B, Visit 3: Beverage C, Visit 4: Beverage D, Visit 5: Beverage E).
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals capable of providing written informed consent to participate in the study of their own free will
2. Age: 18 years or older and 65 years or younger
3. Individuals capable of understanding the content of this study and adhering to the trial schedule
Key exclusion criteria
1. Individuals with severe heart disease, liver disease, kidney disease, or endocrine disorders
2. Individuals with a history of or currently undergoing treatment for gastrointestinal disorders (e.g., inflammatory bowel disease, irritable bowel syndrome)
3. Individuals allergic to dairy products, soy, or tea
4. Women who are pregnant, may be pregnant, or are breastfeeding
5. Individuals with a history of anemia or currently undergoing treatment for anemia
6. Individuals with sensitivity to caffeine
7. Individuals deemed unsuitable by their primary physician or the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endoclinology and Metabolism
Zip code
602-8566
Address
465, Kajii-cho, Kamigyo-ku
TEL
0752515506
mhama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endoclinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku
TEL
0752515506
Homepage URL
mhama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Masahide Hamaguchi
Funding Source
Organization
Oishii Kenko Inc
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
Kyoto Prefectural University of medicine
Address
465, Kajii-cho, Kamigyo-ku
Tel
0752515506
mhama@koto.kpu-m.ac.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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069496
