UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052532 |
|---|---|
| Receipt number | R000059940 |
| Scientific Title | Clinical pharmacological test of calcium alginate capsules -Optimization study of postprandial serum triglyceride elevation suppression effect (additional preliminary study)- |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2024/04/16 10:42:28 |
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Basic information
Public title
Clinical pharmacological test of calcium alginate capsules -Optimization study of postprandial serum triglyceride elevation suppression effect (additional preliminary study)-
Acronym
Triglyceride elevation suppression test of calcium alginate capsules (additional preliminary study).
Scientific Title
Clinical pharmacological test of calcium alginate capsules -Optimization study of postprandial serum triglyceride elevation suppression effect (additional preliminary study)-
Scientific Title:Acronym
Optimization test of postprandial serum triglyceride elevation suppression effect of calcium alginate capsules (additional preliminary study).
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effect of calcium alginate capsules on suppressing elevation of blood triglycerides.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area under the curve (AUC) of the postprandial serum triglyceride.
Key secondary outcomes
The maximum concentration (Cmax) of the postprandial serum triglyceride.
The serum triglyceride level (before, 60, 90, 120, 240 and 360 minutes after the fat food load).
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
Stage1: Placebo capsule
Stage2: Test substance A capsule
Stage3: Test substance B capsule
Fat Loading Food d: Corn Oil Suspended with 3% Gum Arabic
After eating the fat loading food within 3 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
Stage1: Test substance A capsule
Stage2: Test substance B capsule
Stage3: Placebo capsule
Fat Loading Food d: Corn Oil Suspended with 3% Gum Arabic
After eating the fat loading food within 3 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
Stage1: Test substance B capsule
Stage2: Placebo capsule
Stage3: Test substance A capsule
Fat Loading Food d: Corn Oil Suspended with 3% Gum Arabic
After eating the fat loading food within 3 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females aged 20 years or older at the time of informed consent.
In principle, those whose fasting blood TG 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.
People who regularly use medicines, health foods, or supplements that affect blood lipids.
Persons who have some kind of disease and are receiving medication and are deemed unsuitable as subjects by the research doctor.
Persons who may have allergic symptoms related to rubber or latex.
Persons who may develop allergic symptoms regarding fat-loaded foods (corn oil, etc.).
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 whose TG delta C3h (estimated TGCmax) is less than 30 mg/dL in the screening test.
Those who have been diagnosed with bronchial asthma and are receiving treatment, or those who have received treatment in the past.
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.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
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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
| 2023 | Year | 10 | Month | 20 | 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
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 18 | 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=R000059940
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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