UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of egg consumption on serum cholesterol level and antioxidant status
Title of the study (Brief title)	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	Kazuo Kondo
Organization	Ochanomizu University
Division name	Endowed Research Department "Food for Health"
Address	2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL	03-5978-5812
Email	kondo.kazuo@ocha.ac.jp

Public contact
Name of contact person	Kazuo Kondo
Organization	Ochanomizu University
Division name	Endowed Research Department "Food for Health"
Address	2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL	03-5978-5812
Homepage URL
Email	kondo.kazuo@ocha.ac.jp

Sponsor
Institute	Ochanomizu University
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022488