UMIN-CTR Clinical Trial

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
Email	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
Email	Hideyuki_Sasaki@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043703