UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053439 |
|---|---|
| Receipt number | R000060986 |
| Scientific Title | Effect of noodles containing calcium alginate on postprandial blood sugar levels -Placebo-controlled, randomized, double-blind, crossover study- |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/04/16 10:43:12 |
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Basic information
Public title
Effect of noodles containing calcium alginate on postprandial blood sugar levels
-Placebo-controlled, randomized, double-blind, crossover study-
Acronym
Effect of noodles containing calcium alginate on postprandial blood sugar levels
Scientific Title
Effect of noodles containing calcium alginate on postprandial blood sugar levels
-Placebo-controlled, randomized, double-blind, crossover study-
Scientific Title:Acronym
Effect of noodles containing calcium alginate on postprandial blood sugar levels
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of calcium alginate-containing noodles on suppressing postprandial blood sugar rise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum postprandial blood sugar level (Cmax)
Key secondary outcomes
Area under the postprandial blood glucose level time curve AUC (0-120 minutes)
Blood sugar levels at each measurement point (before meals, 15, 30, 45, 60, 90, 120 minutes after meals)
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
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 noodles
Stage II: Alginic acid-containing noodles A
Stage III: Alginic acid-containing noodles B
Eat the test food in 5 minutes.
*The order of intervention will be Stage I, Stage II, and Stage III, with single intake.
*The washout period is one week or more.
Interventions/Control_2
Stage I: Alginic acid-containing noodles A
Stage II: Alginic acid-containing noodles B
Stage III: Placebo noodles
Eat the test food in 5 minutes.
*The order of intervention will be Stage I, Stage II, and Stage III, with single intake.
*The washout period is one week or more.
Interventions/Control_3
Stage I: Alginic acid-containing noodles B
Phase II: Placebo noodles
Stage III: Alginic acid-containing noodles A
Eat the test food in 5 minutes.
*The order of intervention will be Stage I, Stage II, and Stage III, with single intake.
*The washout period is one week or more.
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
Men and women who are 18 years of age or older at the time of obtaining consent.
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
Persons who are taking medicines or supplements that may affect sugar metabolism.
Currently undergoing treatment for diabetes or who is judged to need treatment.
Persons with serious diseases such as diabetes, liver disease, kidney disease, hypertension, ischemic heart disease, digestive system disease, etc., or those with a history of such diseases.
Persons who have some kind of disease and are receiving medication and are deemed unsuitable as subjects by the research doctor.
person.
Persons who regularly use medicines, health foods, or supplements that affect blood lipids.
Persons who are at risk of developing allergic symptoms regarding the test noodles (flour, etc.).
Persons whose BMI value obtained from the temporary registration questionnaire falls outside the 95% confidence interval from the average BMI value of all applicants.
Persons whose fasting blood sugar level is higher than 125 mg/dL or lower than 60 mg/dL as a result of the screening test.
Persons whose HbA1c (NGSP) value is 6.5% or higher as a result of the screening test.
If any of the screening test results are positive for HIV antigen/antibody, HBV, HCV, or syphilis.
Persons with obvious abnormalities found in hematological or biochemical tests.
Target sample size
9
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
Faculty of Pharmacy
Zip code
3700033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
0273521180
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
3700033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
0273521180
Homepage URL
s-kimura@takasaki-u.ac.j
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
Takasaki University of Health and Welfare Research Ethics Review Committee
Address
37-1 Nakaorui-cho, 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
| 2024 | Year | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060986
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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