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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031681
Receipt No. 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

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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
Email 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
Email clinic@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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