UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical test to consider the body fat reductional effect by taking functionality egg.
Title of the study (Brief title)	The clinical test to consider the body fat reductional effect by taking functionality egg.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Graduate School of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Seigo Isozaki
Organization	Anti-Aging Bank Co.,Ltd.
Division name	Clinical test support team
Address	3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo
TEL	03-5577-1010
Homepage URL
Email	isozaki@antiaging-bank.com

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

Funding Source
Organization	Nosan Corporation
Organization
Division
Category of Funding Organization	Profit organization
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	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

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/article/2016/GS16-16.pdf
Results
Other related information

Management information
Registered date	2014 Year 12 Month 29 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018684