UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lactic femented egg white improves visceral fat obesity in Japanese subgects: double-blind, parallel-arm design
Title of the study (Brief title)	Lactic femented egg white improves visceral fat obesity in japanese subgects
Region	Japan

Condition
Condition	veseral fat obesity
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We comfirmed that eating the lactic fermemted egg white(LE) decreases visceral fat by the double-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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
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 12weeks. We checked thier visceral fats in baseline and week 12 of intake and abdominal girth in baseline ,week6,and week12.
Interventions/Control_2	The subjects intake the beverages with or milk protein 8g each day about 12weeks. We checked thier visceral fats in baseline and week 12 of intake and abdominal girth in baseline ,week6,and week12.
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	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 postmenopauasal and youger than 70 years old. Body mass index (>=25) The person who does not take medicine.
Key exclusion criteria	1
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
Anticipated trial start date	2013 Year 03 Month 13 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	2017 Year 04 Month 11 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030810