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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031767
Receipt No. 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

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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
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

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
URL(English) https://upload.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


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