UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039211 |
|---|---|
| Receipt number | R000044720 |
| Scientific Title | Optimization test of lowering effects on blood triglyceride level of alginate-containing noodles (preliminary test) |
| Date of disclosure of the study information | 2020/01/21 |
| Last modified on | 2023/07/26 09:37:39 |
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Basic information
Public title
Optimization test of lowering effects on blood triglyceride level of alginate-containing noodles (preliminary test)
Acronym
Effect on blood triglyceride level of alginate-containing noodles (preliminary test)
Scientific Title
Optimization test of lowering effects on blood triglyceride level of alginate-containing noodles (preliminary test)
Scientific Title:Acronym
Effect on blood triglyceride level of alginate-containing noodles (preliminary test)
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation into the effect on blood triglyceride level of alginate-containing noodles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect on blood triglyceride level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
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
Placebo group 1
For 2 or 4 weeks
Once a week
Interventions/Control_2
Placebo group 2 or Tested group 1
For 2 or 4 weeks
Once a week
Interventions/Control_3
Tested group 2
For 2 or 4 weeks
Once a week
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
Key inclusion criteria
Healthy male volunteer over the age of 20
Key exclusion criteria
Person that
1. feels this study is inconvenient to everyday life.
2. takes medication such as hyperlipidemic drugs. (e.g. Person undergoing treatment for hyperlipidemia.)
3. has one or more diseases and is under medical treatment.
4. may cause allergic symptoms with regard to test noodles (wheat flour, buckwheat, eggs).
5. is liable to experience allergic symptoms from corn oil or alcohol.
Target sample size
4
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
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
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
| 2020 | Year | 01 | Month | 21 | 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
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 21 | 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=R000044720
