UMIN-CTR Clinical Trial

Public title

The clinical test to consider the body fat reductional effect by taking functionality egg.

Acronym

The clinical test to consider the body fat reductional effect by taking functionality egg.

Scientific Title

The clinical test to consider the body fat reductional effect by taking functionality egg.

Scientific Title:Acronym

The clinical test to consider the body fat reductional effect by taking functionality egg.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The age as of the consent brief merit of the test participation is less than 65 years old more than 40 years old, and BMI (Kg/m2) compares and examines men and women of more than 25 less than 30 in the double blind way which usually made egg the subject with opposition using FatScan abdominal fat amount measurement and all kinds' measurement parameter using a CT scan photography picture about a body fat reduction action by taking functionality egg for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

FatScan abdominal fat amount measurement using a CT scan photography picture.

Key secondary outcomes

The weight, the percent of body fat, BMI measurement, around the blood pressure/pulse measurement, abdomen and buttocks chief measurement, hematology-like check, blood biochemistry-like check, blood special method inspection, urine general check, urine special method inspection, questionnaire survey and questioning by a subjective diary (A defecation investigation is included.) and questioning by a doctor

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test group
1 a day of functionality egg is taken for 12 weeks.

Interventions/Control_2

Contorol group
1 a day of normal egg is taken for 12 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

Age-lower limit

40

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)The age as of the consent brief merit of the test participation is the man and the lady who are less than 65 years old more than 40 years old.
2)The person who is being a healthy person and isn't treating it with some diseases at present.
3)BMI (Kg/m2) is a person of more than 25 less than 30.
4)A chief around the abdomen is a person of more than 85 cm of man and more than 90 cm of lady.
5)The person who can apply for participation and agree with final examination participation about a document voluntarily when he had the enough explanation about the purpose of the final examination and the contents, and there was agreement ability, and understanding well.
6)A test responsibility doctor is the person who admitted participation in the final examination to be suitable.

Key exclusion criteria

1)The person who has trouble with some chronic malady and has a medicine medical treatment at present.
2)Severe hepatopathy, kidney, heart disease, lung, digestive organ (including stomach removal), organ obstacle, diabetes and thyroid disease, additionally, the person with whom the past is infected in a severe disease.
3)A person with the fear which indicates the allergic reaction in white, yolk (egg) and iodine, also, medical supplies, additionally, the person with fear who causes allergy to severe foods in a food.
4)AST (GOT), ALT (GPT) and gamma-GT (gamma-GTP) are more than 1.5 times of person of the standard value.
5)A person of more than 2.0 times by which a fat matter related index is the standard value (in HDL-cho, person of less than 1/2).
6)Lithic acid (UA) is a person beyond 8.5mg/dl.
7)HbA1c (NGSP) is a person beyond 7.0mg/dl.
8)Person with the medical history of the disease and a present case history of hepatitis.
9)The systolic blood pressure, more than 160 mmHg or the expansion period blood pressure is more than 100 mmHg of person.
10)Person with high anemia.
etc.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Yonei

Organization

Graduate School of Life and Medical Sciences,Doshisha University

Division name

Anti-Aging Medical Research Center

Zip code

Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp

Name of contact person

1st name
Middle name
Last name	Seigo Isozaki

Organization

Anti-Aging Bank Co.,Ltd.

Division name

Clinical test support team

Zip code

Address

3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo

TEL

03-5577-1010

Homepage URL

Email

isozaki@antiaging-bank.com

Institute

Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha Univercity

Institute

Department

Personal name

Organization

Nosan Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

一般社団法人オリエンタル労働衛生協会東京支部
オリエンタル上野健診センター

Date of disclosure of the study information

2015

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.toukastress.jp/webj/article/2016/GS16-16.pdf

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

12

Month

22

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

29

Day

Last modified on

2016

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018684