UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042187 |
|---|---|
| Receipt number | R000047902 |
| Scientific Title | Study on correlation between EPA concentration in erythrocyte membranes and hemolysis on young women |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2024/04/28 16:24:25 |
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Basic information
Public title
Study on correlation between EPA concentration in erythrocyte membranes and hemolysis on young women
Acronym
Correlation between EPA concentration in erythrocyte membranes and hemolysis
Scientific Title
Study on correlation between EPA concentration in erythrocyte membranes and hemolysis on young women
Scientific Title:Acronym
Correlation between EPA concentration in erythrocyte membranes and hemolysis
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on correlation of EPA supplementation with hemolysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatty acid composition of erythrocyte membranes and hemolysis indicators by physical stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: fish oil
2.8g/day, 6 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women
Key exclusion criteria
1) Subjects who are likely to have allergic symptoms due to the tested component
2) Subjects who are suffering from diseases and who are visiting hospital, medication or treatment
3) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yurie |
| Middle name | |
| Last name | Hara |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, College of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, 194-8610, Japan
TEL
042-739-8267
hara_y@agr.tamagawa.ac.jp
Public contact
Name of contact person
| 1st name | Yurie |
| Middle name | |
| Last name | Hara |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, College of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, 194-8610, Japan
TEL
042-739-8267
Homepage URL
hara_y@agr.tamagawa.ac.jp
Sponsor or person
Institute
Tamagawa University
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Showa Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Tamagawa University
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, 194-8610, Japan
Tel
042-739-8666
t.instit@adm.tamagawa.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
玉川大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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
19
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results will be published after the paper is published.
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 | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047902
