UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059309 |
|---|---|
| Receipt number | R000067490 |
| Scientific Title | Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/21 10:26:47 |
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Basic information
Public title
Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake
Acronym
Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake
Scientific Title
Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake
Scientific Title:Acronym
Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of consumption of Glucolacto-oligosaccharides on blood glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose levels (incremental AUC, Cmax, delta Cmax, Tmax, and change of blood glucose and delta postprandial blood glucose)
Serum insulin levels (incremental AUC, Cmax, delta Cmax and change of insulin secretion and delta value)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take the test food 1 containing Glucolacto-oligosaccharides within 5 min.
Interventions/Control_2
Take the placebo food 1 containing sucrose within 5 min.
Interventions/Control_3
Take the test food 2 containing Glucolacto-oligosaccharides within 5 min.
Interventions/Control_4
Take the placebo food 2 containing glucose within 5 min.
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Subjects who are Japanese men aged 20 to below 65 years at the time of consent acquisition.
2. Subjects whose BMI are 18.5 or more and less than 25.
3. Subjects whose fasting blood glucose level are less than 126 mg/dL on SCR blood test.
4. Subjects who can obtaining time-dependently blood sampling.
5. Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who have severe or progressive diseases, such as cardiac-, hepatic-, kidney-, heart-, lung- and digestive- diseases, diabetes mellitus, rheumatoid arthritis, neurological disease, psychiatric disorders, endocrine disease, and other diseases.
2. Subjects who are taking medications for diabetes mellitus.
3. Subjects who have food allergy.
4. Subjects who are aware of lactose intolerance.
5. Subjects with a history of stomach or small intestine resection (excluding polypectomy and minor surgery).
6. Subjects who are heavy drinkers with an average daily intake of over 60 g in terms of pure alcohol.
7. Subjects with Tmax of postprandial blood glucose levels at 90min.
8. Subjects who are current smoker.
9. Subjects who fast or miss a meal (4 or more days a week) on a regular basis.
10. Subjects with carbohydrate-restricted diet (1 or more days a week).
11. Subjects who donate blood more than 200 mL of blood and/or blood components within 1 month prior to the date of obtaining informed consent.
12. Subjects who have participated in other clinical trials within 1 month prior to the date of obtaining informed consent (excluding observation study).
13. Subjects who are judged unsuitable for this study by principal investigator or sub-investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Clinic Director
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
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 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
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
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
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 | 10 | Month | 16 | 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 | 22 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 10 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067490
