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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name