UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020237 |
|---|---|
| Receipt number | 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 23:55:06 |
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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
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
fujibayashi@atf.setsunan.ac.jp
Sponsor or person
Institute
Division of Physical and Health Education Setsunan university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023368
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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