UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056513 |
|---|---|
| Receipt number | R000064580 |
| Scientific Title | Effect of calcium alginate-containing noodles on triglycerides. Placebo-controlled randomized double-blind crossover study. |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2025/09/10 15:50:44 |
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Basic information
Public title
Effect of calcium alginate-containing noodles on triglycerides.
Placebo-controlled randomized double-blind crossover study.
Acronym
Effect of calcium alginate-containing noodles on triglycerides.
Scientific Title
Effect of calcium alginate-containing noodles on triglycerides.
Placebo-controlled randomized double-blind crossover study.
Scientific Title:Acronym
Effect of calcium alginate-containing noodles on triglycerides.
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 increases in blood triglyceride levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area under the curve (AUC, delta AUC) of the postprandial serum triglyceride.
The serum triglyceride level C, delta C.
The maximum concentration (Cmax, delta Cmax) of the postprandial serum triglyceride.
Key secondary outcomes
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
Males and females aged 18 years or older at the time of informed consent.
In principle, those whose fasting blood triglyceride level at the time of screening test is less than 150mg/dL.
Those who fully understand the purpose and safety of this research specified in the research cooperation consent form and have obtained consent.
Key exclusion criteria
Persons receiving treatment, medication, or lifestyle guidance from a doctor due to dyslipidemia or diabetes.
Persons who regularly use medicines, health foods, or supplements that affect blood lipids.
Those with serious illnesses, such as diabetes, liver disease, kidney disease, high blood pressure, ischemic heart disease, or digestive system disease, or those with a history of such illnesses.
Those taking medicines or supplements that may affect glucose metabolism.
Persons who have some kind of disease and are receiving medication and are deemed unsuitable as subjects by the research doctor.
Persons whose HIV antigen/antibody, HBs antigen, HCV antibody, or syphilis test result was positive at the time of screening.
Persons with obvious abnormalities found in hematological or biochemical tests.
Those who are pregnant, wish to become pregnant during the test, or are breastfeeding.
Persons who had difficulty collecting blood during the screening test.
Persons whose triglyceride delta C3h (estimated TGCmax) is less than 30 mg/dL in the screening test.
Persons who may experience allergic symptoms regarding the test noodles (flour, etc.)
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
General Incorporated Association, Kendai Translational Research Center
Division name
Clinical Research Department
Zip code
3700002
Address
450-1-A Hidaka-machi, Takasaki City, Gunma Prefecture
TEL
0273954316
kimura.ktrc@gmail.com
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
General Incorporated Association, Kendai Translational Research Center
Division name
Clinical Research Department
Zip code
3700002
Address
450-1-A Hidaka-machi, Takasaki City, Gunma Prefecture
TEL
0273954316
Homepage URL
kimura.ktrc@gmail.com
Sponsor or person
Institute
General Incorporated Association, Kendai Translational Research Center
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association, 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 | 12 | Month | 25 | 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 | 11 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064580
