UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031681 |
|---|---|
| Receipt number | R000036187 |
| Scientific Title | Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men:doule-blind,parallel-armed study |
| Date of disclosure of the study information | 2018/03/12 |
| Last modified on | 2018/03/12 15:10:32 |
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Basic information
Public title
Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men:doule-blind,parallel-armed study
Acronym
Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men
Scientific Title
Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men:doule-blind,parallel-armed study
Scientific Title:Acronym
Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men
Region
| Japan |
Condition
Condition
veseral fat obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We comfirmed that minimale effective dose of fermemted egg white(LE) on the visceral fat by the coule-blind,parallel-arm design examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects intake the beverages with lactic fermented egg white 8g each day about 8 weeks. We checked thier visceral fats in baseline and week 8 of intake and abdominal girth in baesline and week 8.
Interventions/Control_2
The subjects intake the beverages with milk protein 8g each day about 8 weeks. We checked thier visceral fats in baseline and week 8 of intake and abdominal girth in baesline and week 8.
Interventions/Control_3
The subjects intake the beverages with lactic fermented egg white 6g each day about 8 weeks. We checked thier visceral fats in baseline and week 8 of intake and abdominal girth in baesline and week 8.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The male subjects are older than 40 years old and youger than 70 years old.
The female subjects are postmenopausal and youger than 70 years old.
Bodymass index(>=24)
The person who dose not take medicine
Key exclusion criteria
The person who was told not to be suitable by the judgment of the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tanaka |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome,Toshimaku,Tokyo.
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome,Toshimaku,Tokyo.
TEL
03-3918-6181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corpration
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
女子栄養大学 栄養クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 12 | 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
| 2012 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 14 | 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
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036187
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| Registered date | File name |
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| Registered date | File name |
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