UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031767
Receipt number R000036263
Scientific Title Safty evaluation of excessive intake of egg white peptide combination food
Date of disclosure of the study information 2018/03/18
Last modified on 2018/03/16 17:52:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Safty evaluation of excessive intake of egg white peptide combination food

Acronym

Safty evaluation of excessive intake of egg white peptide combination food

Scientific Title

Safty evaluation of excessive intake of egg white peptide combination food

Scientific Title:Acronym

Safty evaluation of excessive intake of egg white peptide combination food

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We made the functional foods included egg white peptide. we planed safety test for adults.The Subjects took 15g egg white peptide each day for 4weeks and checked the blood and urine in baseline and 2weeks later and 4weeks later.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We checked the blood and urine in baseline and 2weeks later and 4weeks later.

Key secondary outcomes

AST,ALT,r-GTP,ALP,ChE,LDH,TP,ALB,A/G,ZTT,TTT,T-bil,T-CHO,HDL-C,LDL-C,GLC,HbA1c,BUN,Cr


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects eat egg white peptide 15g in a day for 28days. we checked thier blood and urine tests in baseline,2 weeks later and 4 weeks later.

Interventions/Control_2


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

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

The person who has egg allergy.
The person who was told not to be suitable by the judgment of the doctor.

Target sample size

22


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Tnaka

Organization

Kagawa Nutrition University

Division name

Nutrition Clinic

Zip code


Address

3-24-3 Komagome,Toshima,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

Kgawa Nutrition University

Division name

Nutrition Clinic

Zip code


Address

3-24-3 Komagome,Toshima,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

2018 Year 03 Month 18 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

As a result of having taken in the food including 15 g of egg white peptide for 28 days, safety did not have the problem.

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

2018 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 03 Month 16 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 16 Day

Last modified on

2018 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036263


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name