UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061688 |
|---|---|
| Receipt number | R000070527 |
| Scientific Title | A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters: a single blind, randomized, parallel-group, non-inferiority study |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 10:00:31 |
* 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
A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters
Acronym
A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters
Scientific Title
A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters: a single blind, randomized, parallel-group, non-inferiority study
Scientific Title:Acronym
A study to evaluate the effects of regular consumption of a test product on glycemic-related parameters
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate that regular consumption of a test product does not worsen glycemic-related parameters compared with placebo, thereby supporting increased consumption of a test product.
Basic objectives2
Others
Basic objectives -Others
Non-inferiority study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in HbA1c from before the intervention to 24 weeks after the intervention
Key secondary outcomes
a. The measured value of HbA1c at 24 weeks after the intervention
b. The measured value of HbA1c at 12 weeks after the intervention and the change from before the intervention
c. The measured values of AST, ALT, gamma-glutamyl transpeptidase, ALP, total bilirubin, and total protein at 12 and 24 weeks after the intervention, and their changes from before the intervention
d. The measured values of fasting plasma glucose, 2-hour plasma glucose during OGTT, and Matsuda index at 12 and 24 weeks after the intervention, and their changes from before the intervention
e. The measured values of Fatty Liver Index (FLI) and NAFLD Fibrosis Score (NFS) at 12 and 24 weeks after the intervention, and their changes from before the intervention
f. The measured values of body weight, BMI, and waist circumference at 12 and 24 weeks after the intervention, and their changes from before the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Consumption of the test product for 24 weeks
Interventions/Control_2
Consumption of the placebo for 24 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese male and female participants aged >= 18 and < 64 years with HbA1c levels within the normal range or slightly elevated (HbA1c < 6.5%) who do not meet any exclusion criteria, express willingness to participate in the study, and provide informed consent online
Key exclusion criteria
1. Individuals receiving treatment or medication for diabetes
2. Individuals who habitually consume Foods for Specified Health Uses or Foods with Functional Claims intended to suppress postprandial blood glucose elevation at least three times per week
3. Individuals who habitually consume 100% vegetable juice or vegetable-fruit mixed juice at least three times per week
4. Individuals with food allergies to the test beverage
5. Individuals with alcohol hypersensitivity severe enough to make alcohol disinfection difficult
6. Individuals planning to become pregnant or to breastfeed during the study period
7. Individuals with anemia detected on blood testing (Hb < 13.0 g/dL for adult males and Hb < 12.0 g/dL for non-pregnant adult females), or individuals for whom interpretation of HbA1c is considered difficult due to blood donation of >= 200 mL within the past month or >= 400 mL within the past three months
8. Individuals with chronic diseases requiring daily medication
9. Individuals diagnosed with liver cirrhosis or chronic hepatitis B or C
10. Individuals with a history of gastrointestinal surgery (e.g., gastrectomy or bypass surgery)
11. Individuals unable to maintain a stable daily routine, such as those working exclusively night shifts or extreme shift schedules
12. Individuals participating in other clinical studies at the start of this study
13. Individuals deemed unsuitable by the principal investigator or sub-investigator
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Waki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287362935
Naoko_Waki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO, Inc.
Division name
R&D Department
Zip code
1120002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo
TEL
0338180610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME 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
0357933623
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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | 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 | 05 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 15 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070527
