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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020237
Receipt No. R000023368
Scientific Title Clarification of serum lipid profile in young men
Date of disclosure of the study information 2015/12/16
Last modified on 2015/12/16

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Basic information
Public title Clarification of serum lipid profile in young men
Acronym Serum lipid profile in heathy young men
Scientific Title Clarification of serum lipid profile in young men
Scientific Title:Acronym Serum lipid profile in heathy young men
Region
Japan

Condition
Condition Healthy men
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the serum lipid profile between healthy young men and rugby football players

The rugby football players are already measured in other study.
Basic objectives2 Others
Basic objectives -Others To compare the serum lipid profile between healthy young men and rugby football players

The rugby football players are already measured in other study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HDL cholesterol
Key secondary outcomes Dietary habits
Body composition
Genotype (related to obesity, HDL cholesterol and muscle)
Maximal voluntary contraction
Autonomic nerve activity
Blood biochemical parameters

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Age >= 18
2) Male
3) Sedentary
Key exclusion criteria 1) Medication prescribed by a doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujibayashi Mami
Organization Setsunan University
Division name Division of Physical and Health Education
Zip code
Address 17-8, Ikedanakamachi, Neyagawa, Osaka, 572-8508, Japan
TEL +81-72-839-9193
Email fujibayashi@atf.setsunan.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fujibayashi Mami
Organization Setsunan university
Division name Division of Physical and Health Education
Zip code
Address 17-8, Ikedanakamachi, Neyagawa, Osaka, 572-8508, Japan
TEL +81-72-839-9193
Homepage URL
Email fujibayashi@atf.setsunan.ac.jp

Sponsor
Institute Division of Physical and Health Education Setsunan university
Institute
Department

Funding Source
Organization school fund
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 12 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design
Prospective cohort study

Recruitment
Healthy male in Setsunan University in 2015 to 2018 year.

Measurements
Dietary habits, body composition, genotype, maximal voluntary contraction, autonomic nerve activity, blood biochemical parameters

Management information
Registered date
2015 Year 12 Month 16 Day
Last modified on
2015 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023368

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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