UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016081 |
|---|---|
| Receipt number | R000018684 |
| Scientific Title | The clinical test to consider the body fat reductional effect by taking functionality egg. |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2016/12/21 12:06:28 |
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Basic information
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
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
| 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
yyonei@mail.doshisha.ac.jp
Public contact
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
isozaki@antiaging-bank.com
Sponsor or person
Institute
Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha Univercity
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018684
