UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044544 |
|---|---|
| Receipt number | R000050809 |
| Scientific Title | Research on clinical application of non-invasive triglyceride measuring device |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2023/12/19 20:29:54 |
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Basic information
Public title
Research on clinical application of non-invasive triglyceride measuring device
Acronym
Research on clinical application of non-invasive triglyceride measuring device
Scientific Title
Research on clinical application of non-invasive triglyceride measuring device
Scientific Title:Acronym
Research on clinical application of non-invasive triglyceride measuring device
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the conversion formula for calculating the serum triglyceride level using the measured values of the non-invasive triglyceride measuring device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride level using a non-invasive triglyceride measuring device
Key secondary outcomes
Serum triglyceride level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take Ooft cream and measure triglyceride after meals (before, 120 minutes, 240 minutes)
Triglyceride level using a non-invasive triglyceride measuring device/ Serum triglyceride level
Interventions/Control_2
Interventions/Control_3
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 20 and 65
Key exclusion criteria
Those who may cause allergic symptoms to the test meal (offt cream)
Those with lactose intolerance
Those who have some kind of illness and regularly use drugs
Those who may cause allergic symptoms regarding alcohol
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui, Takasaki city, Gunma
TEL
0273521290
mtakeuchi@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui, Takasaki city, Gunma
TEL
0273521290
Homepage URL
mtakeuchi@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1 Nakaorui, Takasaki city, Gunma
Tel
0273521290
mune@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
高崎健康福祉大学附属クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
51
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
