UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026949
Receipt number R000030810
Scientific Title Lactic femented egg white improves visceral fat obesity in Japanese subgects: double-blind, parallel-arm design
Date of disclosure of the study information 2017/04/20
Last modified on 2017/04/11 15:23:22

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Basic information

Public title

Lactic femented egg white improves visceral fat obesity in Japanese subgects: double-blind, parallel-arm design

Acronym

Lactic femented egg white improves visceral fat obesity in japanese subgects

Scientific Title

Lactic femented egg white improves visceral fat obesity in Japanese subgects: double-blind, parallel-arm design

Scientific Title:Acronym

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

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 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


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 20 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

2013 Year 03 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name