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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020056
Receipt No. R000023164
Scientific Title The safety study of a supplement containing chicken breast meat extract supplements for healthy volunteer with long-term ingestion
Date of disclosure of the study information 2017/04/02
Last modified on 2016/05/30

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Basic information
Public title The safety study of a supplement containing chicken breast meat extract supplements for healthy volunteer with long-term ingestion
Acronym The safety study of a supplement containing chicken breast meat extract supplements for healthy volunteer with long-term ingestion
Scientific Title The safety study of a supplement containing chicken breast meat extract supplements for healthy volunteer with long-term ingestion
Scientific Title:Acronym The safety study of a supplement containing chicken breast meat extract supplements for healthy volunteer with long-term ingestion
Region
Japan

Condition
Condition Healthy Volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Healthy Volunteer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight
Doctor's questions
Adverse event
Key secondary outcomes

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 This study examines the safety of a supplement containing chicken breast meat extract for 12 weeks with long-term ingestion.
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
64 years-old >=
Gender Male and Female
Key inclusion criteria Japanese healthy males and females aged 20-64 years
Key exclusion criteria (1) Subjects who routinely use health food containing plasmalogens, imidazole dipeptide, and ferlic acid.
(2) Subjects who have under treatment or a history of serious disease
(3) Subjects who using medical products, and subjects who have a history of serious disease.
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects judged as unsuitable for the current study by the investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kotoura
Organization Marudai Food Co., Ltd
Division name Central Reseach Institute
Zip code
Address 21-3, Midori-cho, Takatsuki-shi, Osaka, Japan
TEL 072-661-2552
Email kotoura_satoshi@marudai.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Watanabe
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email n.watanabe@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization Marudai Food Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 02 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
2015 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 04 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
2015 Year 12 Month 03 Day
Last modified on
2016 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023164

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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