UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061018 |
|---|---|
| Receipt number | R000069822 |
| Scientific Title | A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 13:53:50 |
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Basic information
Public title
A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels
Acronym
A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels
Scientific Title
A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels
Scientific Title:Acronym
A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of frozen dessert in blood glucose levels management in healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incremental Area Under the Curve (IAUC)120 min of blood glucose level
Key secondary outcomes
1. Blood glucose levels (blood glucose levels at each time point, the maximum blood concentration (Cmax), the time to maximum blood concentration (Tmax))
2. Insulin (blood insulin levels at each time point, IAUC120 min, Cmax, Tmax)
3. Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) (GIP, GLP-1 at each point, IAUC120 min, Cmax, Tmax)
4. Adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food -> The test food1 -> The test food2
*Take each test food over five min
Interventions/Control_2
Control food -> The test food2 -> The test food1
*Take each test food over five min
Interventions/Control_3
The test food1 -> The test food2 -> Control food
*Take each test food over five min
Interventions/Control_4
The test food1 -> Control food -> The test food2
*Take each test food over five min
Interventions/Control_5
The test food2 -> Control food -> The test food1
*Take each test food over five min
Interventions/Control_6
The test food2 -> The test food1 -> Control food
*Take each test food over five min
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. Men and women aged 20 or more and less than 65 at the time of agreement to participate in this study
Key exclusion criteria
1. Individuals whose fasting blood glucose level is 126 mg/dL or more at screening (Scr)
2. Individuals whose hemoglobin A1c (HbA1c) is 6.5% or more at Scr
3. Individuals who take medicines that may influence the blood glucose level
4. Individuals who are currently taking "Foods for Specified Health Uses" or "Foods with Function Claims"
5. Individuals who are undergoing medical treatment or have a serious medical history of any disease such as liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system
6. Individuals who have drug allergy or food allergy (such as eggs, milk ingredients, soybeans)
7. Individuals who are pregnant, planning to become pregnant during this study, or lactating
8. Individuals who are collected 400 mL or more of blood due to blood donation within 8 weeks before the agreement to participate in this study
9. Individuals who are dental decay or hypersensitive teeth
10. Individuals who are participating in other clinical trials or plan to participate in another study during this study
11. Individuals who are judged as ineligible to participate in this study based on the results of participant' background, physical finding, consultation, physical examination, and clinical examination, by principal physician or sub-physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Morinaga Milk Industry CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry CO., 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 23 | 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 | 03 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069822
