UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Minimal Effective dose of Lactic fermented egg white on the visceral fat obesity in Japanese men:doule-blind,parallel-armed study
Title of the study (Brief title)	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	Akira Tanaka
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3 Komagome,Toshimaku,Tokyo.
TEL	03-3918-6181
Email	clinic@eiyo.ac.jp

Public contact
Name of contact person	Keiko Kamachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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