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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043618
Receipt No. R000049807
Scientific Title Clinical study to analyze the effect of tuna (sashimi, red meat) on the accumulation of selenonein, anti-oxidative activity and expression of sirtuins in human peripheral blood mononuclear cells and oral mucosa cells.
Date of disclosure of the study information 2021/03/16
Last modified on 2021/03/15

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Basic information
Public title Clinical study to analyze the effect of tuna (sashimi, red meat) on the accumulation of selenonein, anti-oxidative activity and expression of sirtuins in human peripheral blood mononuclear cells and oral mucosa cells.
Acronym The effect of tuna meat on the levels of biomarkers for healthy condition.
Scientific Title Clinical study to analyze the effect of tuna (sashimi, red meat) on the accumulation of selenonein, anti-oxidative activity and expression of sirtuins in human peripheral blood mononuclear cells and oral mucosa cells.
Scientific Title:Acronym The effect of tuna meat on the levels of biomarkers for healthy condition in blood and oral mucosal cells.
Region
Japan

Condition
Condition Healthy donors
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study to analyze the effect of tuna (sashimi, red meat) on the expression of sirtuins, the accumulation of selenonein and anti-oxidative activity in peripheral blood mononuclear cell and oral mucosal cells.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To analyze the effect of tuna (sashimi, red meat) on the expression of sirtuins, the accumulation of selenonein and anti-oxidative activity in peripheral blood mononuclear cell and oral mucosal cells.
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Tuna meat
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
69 years-old >=
Gender Male and Female
Key inclusion criteria Healthy donors without allergy of fish meat
Key exclusion criteria Allergy of fish meat
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Yudoh
Organization St. Marianna University School of Medicine
Division name Institute of Medical Science
Zip code 2168512
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki City, Japan
TEL 0449778111
Email yudo@marianna-u.ac.jp

Public contact
Name of contact person
1st name Kazuo
Middle name
Last name Yudoh
Organization St.Marianna University School of Medicine
Division name Institute of Medical Science
Zip code 2168512
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
TEL 0449778111
Homepage URL
Email yudo@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
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 University ethics committee in St. Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
Tel 0449778111
Email k-sienbu.mail@marianna-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
2021 Year 03 Month 16 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 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 03 Month 15 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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