UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048540 |
|---|---|
| Receipt number | R000055306 |
| Scientific Title | Clinical pharmacology study of calcium alginate capsules -optimization study of inhibition of postprandial blood glucose level elevation- |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2023/07/26 10:11:18 |
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Basic information
Public title
Clinical pharmacology study of calcium alginate capsules -optimization study of inhibition of postprandial blood glucose level elevation-
Acronym
Postprandial blood glucose elevation inhibitory effect of calcium alginate capsules
Scientific Title
Clinical pharmacology study of calcium alginate capsules -optimization study of inhibition of postprandial blood glucose level elevation-
Scientific Title:Acronym
Postprandial blood glucose elevation inhibitory effect optimization test of calcium alginate capsules
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of calcium alginate capsules on suppressing postprandial blood glucose elevation will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The maximum blood concentration (Cmax) of the postprandial blood glucose
The incremental area under the curve (IAUC) of the postprandial blood glucose
The blood glucose level (before consumption of the carbohydrate load, 15,30,45,60,90 and 120 minutes after consumption of the carbohydrate load)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Stage I: Placebo capsule
Stage II: Test substance A capsule
Stage III: Test substance B capsule
Carbohydrate load: Udon noodles 180g
After eating the carbohydrate load within 5 minutes, take the test substance capsule or placebo capsule with water.
* The order of intervention is stage I, stage II, stage III, and a single dose.
* The washout period is one week or longer.
Interventions/Control_2
Stage I: Test substance A capsule
Stage II: Test substance B capsule
Stage III: Placebo capsule
Carbohydrate load: Udon noodles 180g
After eating the carbohydrate load within 5 minutes, take the test substance capsule or placebo capsule with water.
* The order of intervention is stage I, stage II, stage III, and a single dose.
* The washout period is one week or longer.
Interventions/Control_3
Stage I: Test substance B capsule
Stage II: Placebo capsule
Stage III: Test substance A capsule
Carbohydrate load: Udon noodles 180g
After eating the carbohydrate load within 5 minutes, take the test substance capsule or placebo capsule with water.
* The order of intervention is stage I, stage II, stage III, and a single dose.
* The washout period is one week or longer.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Men and women who are 18 years of age or older at the time of obtaining consent
2.Persons who have fully understood and consented to the purpose and safety of this research specified in the Research Cooperation Consent Manual
Key exclusion criteria
1.Persons whose BMI and body weight do not fit into the normal distribution (95% confidence interval)
2.Persons taking medicines or supplements that may affect glucose metabolism
3.Persons who are currently being treated for diabetes or who are judged to need treatment
4.Persons with serious diseases such as diabetes, liver disease, renal disease, hypertension, ischemic heart disease, digestive system disease, and those with a history of them
5.Persons who may cause allergic symptoms regarding udon noodles (flour, etc.)
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Graduate School of Pharmaceutical Sciences
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
0273521180
Homepage URL
s-kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Kendai Translational Research Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee at Takasaki University of Health and Welfare
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma, Japan
Tel
0273521290
kuwabara@takasaki-u.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 10 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055306
