UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019439 |
|---|---|
| Receipt number | R000022488 |
| Scientific Title | Effect of egg consumption on serum cholesterol level and antioxidant status |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2016/10/26 10:27:22 |
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Basic information
Public title
Effect of egg consumption on serum cholesterol level and antioxidant status
Acronym
Effect of egg consumption on serum cholesterol level and antioxidant status
Scientific Title
Effect of egg consumption on serum cholesterol level and antioxidant status
Scientific Title:Acronym
Effect of egg consumption on serum cholesterol level and antioxidant status
Region
| Japan |
Condition
Condition
Male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of egg consumption on serum cholesterol level and antioxidant status
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum cholesterol, Antioxidant status at before and after intervention (4 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
3 eggs (4 weeks)-> washout-> No egg (4 weeks)
Interventions/Control_2
No egg-> washout-> 3 eggs (4 weeks)
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
| Not applicable |
Gender
Male
Key inclusion criteria
Subjects who are competent to consent
Key exclusion criteria
Subjects who have allergy to eggs
Subjects who are currently taking medication for dyslipidemia
Subjects who eat many eggs in their job
Subjects who have a disorderly dietary life
Subjects who are judged by the doctor as not eligible to this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kondo |
Organization
Ochanomizu University
Division name
Endowed Research Department "Food for Health"
Zip code
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5812
kondo.kazuo@ocha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Kondo |
Organization
Ochanomizu University
Division name
Endowed Research Department "Food for Health"
Zip code
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5812
Homepage URL
kondo.kazuo@ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
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
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 | 10 | Month | 21 | 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
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022488
