UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038348 |
|---|---|
| Receipt number | R000043703 |
| Scientific Title | An observational study of evaluation method for erythrocyte membrane function. (SWE-2019-08) |
| Date of disclosure of the study information | 2019/11/04 |
| Last modified on | 2021/04/22 11:20:54 |
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Basic information
Public title
An observational study of evaluation method for erythrocyte membrane function. (SWE-2019-08)
Acronym
An observational study of evaluation method for erythrocyte membrane function.
Scientific Title
An observational study of evaluation method for erythrocyte membrane function. (SWE-2019-08)
Scientific Title:Acronym
An observational study of evaluation method for erythrocyte membrane function.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory survey of age-related changes in erythrocyte function and effects of polyunsaturated fatty acids on erythrocyte membrane function.
Basic objectives2
Others
Basic objectives -Others
To survey of evaluation method for erythrocyte membrane function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
erythrocyte function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male and Female whose age are 20 years <= age (young) <= 29 years, 65 years <= age (elderly) <= 74 years.
(2) Person who are with less or more seafood consumption.
(3) Person who can visit hospital on designated day.
(4) Person who are able to submit the written informed consents.
Key exclusion criteria
(1) Female in pregnancy, lactation and scheduled pregnancy period.
(2) Person who are attending other studies or attended other studies within the past 4 weeks.
(3) Person who are;
a) With present heart disorder, liver disorder, kidney disorder.
b) With history of cardiac disorder.
c) With diabetes mellitus.
d) Without negative by virus immune serology test result.
e) With previous and present serious disease
(4) Use of product affecting the data of this study, such as medicine and food for specified health use.
(5) Person who are anemia or polycythemia
(6) An irregular life such as shift work
(7) Person who are deemed to be unsuitable by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kaneda |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284 Japan
TEL
050-3182-0654
Yoshihisa_Kaneda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Sasaki |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284 Japan
TEL
050-3182-0683
Homepage URL
Hideyuki_Sasaki@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2019 | Year | 11 | Month | 04 | 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
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
An exploratory survey of age-related changes in erythrocyte function
Management information
Registered date
| 2019 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043703
