UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059237 |
|---|---|
| Receipt number | R000067755 |
| Scientific Title | Effects of Sweetener Intake on Blood Glucose Levels |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/10/10 10:45:58 |
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Basic information
Public title
Effects of Sweetener Intake on Blood Glucose Levels
Acronym
Effects of Sweetener Intake on Blood Glucose Levels
Scientific Title
Effects of Sweetener Intake on Blood Glucose Levels
Scientific Title:Acronym
Effects of Sweetener Intake on Blood Glucose Levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the change of Blood glucose level after sweetener intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Blood insulin level, Breath hydrogen concentrations, VAS (Hunger, Sleepiness, Bloating, Stomach Rumbling)
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of active food
Interventions/Control_2
Single intake of Placebo food
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Healthy men range in age from 30 to 60 at the time of informed consent.
2.Subjects with a BMI of 18.5 or more and less than 25.
3.Subjects who eat three meals a day (allowing up to 3 days of skipping meals per week).
4.Subjects whose defecation frequency are more than 3 times a week.
5.Subjects who are capable of undergoing serial blood sampling.
6.Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects with food allergies.
2. Subjects who suffer from serious disorders of liver, kidney, heart, lung, digestive organs (including gastric resection), diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases.
3. Subjects with a history of resection of the stomach, small intestine, or large intestine (including appendectomy or colonoscopy procedures within one year prior to the consent date).
4. Heavy drinkers (weekly average of 30 g / day or more of pure alcohol).
5. Smoker.
6. Subjects who regularly take supplements and health foods for intestinal function or containing prebiotics (e.g. Oligosaccharide, dietary fiber) , defined as usage at least three days a week continuously for two weeks or more.
7. Subjects who habitually practice carbohydrate restriction (such as Low-Carb, Lo-Carb diets) at least once a week.
8. Subjects using blood glucose-lowering medications, including insulin.
9. Subjects currently taking oral medication for allergic rhinitis or who may take such medication during the study period (excluding those who only use nasal sprays or eye drops).
10. Subjects who donated more than 200ml blood within the past 1 month.
11. Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period.
12. Subjects with fasting blood glucose levels of 126 mg/dL or higher.
13. Shift workers, night workers, or individuals with irregular sleep cycles.
14. Subjects who determine ineligible by the principal investigator or the co-investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kawai |
| Middle name | |
| Last name | Yoshitaka |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
+81-42-632-5810
yoshitaka.kawai@meiji.com
Public contact
Name of contact person
| 1st name | Kakeru |
| Middle name | |
| Last name | Masada |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
+81-42-632-5810
Homepage URL
kakeru.masada@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic
Address
2nd floor, Daiwa Building, 3-3-10 Hongoku-cho, Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
MIJ25C3
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
2025-004
Org. issuing International ID_2
Meiji Co., Ltd.
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067755
