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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038848
Receipt No. R000044244
Scientific Title A study for evaluate bioavailability in healthy adults after the consumption of an component in eggs.
Date of disclosure of the study information 2019/12/12
Last modified on 2019/12/09

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Basic information
Public title A study for evaluate bioavailability in healthy adults after the consumption of an component in eggs.
Acronym A study for evaluate bioavailability in healthy adults after the consumption of an component in eggs.
Scientific Title A study for evaluate bioavailability in healthy adults after the consumption of an component in eggs.
Scientific Title:Acronym A study for evaluate bioavailability in healthy adults after the consumption of an component in eggs.
Region
Japan

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

Objectives
Narrative objectives1 This study aimed to evaluate the plasma concentration in healthy adults consumption of an component in eggs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes plasma concentration of an component in eggs.(Phospholipid)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test product one time.
(3g:Consumption of an component in eggs)
Interventions/Control_2 Oral ingestion of the test product one time.
(2g:Consumption of an component in eggs)
Interventions/Control_3 Oral ingestion of the test product one time.
(1g:Consumption of an component in eggs)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Males and females aged 20 years and older Kewpie corporation member.Individuals who sign the consent document after explanation of this study.
2.Individuals who can stop routinely take proprietary drugs and health foods including beverages.
3.Subjects who can maintain an everyday lifestyle during study period constantly.
Key exclusion criteria 1.Individuals who have serious hepatopathy, (e.g.diabetes mellitus,hepatic disorder,heart disease,renal disorder,cancer) and dyslipidemia,mental disorder.
2.Subjects who are diagnosed for anemia or have treatment history for anemia.
3.Subjects who are active mass (exercise) in everyday life.
4.Subjects who cause food and skin allergy symptoms by food and medicine.
5.Subjects who are pregnant, may be pregnant in near future, or are breast-feeding.
6.Others considered as inappropriate for the study by the physician.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name kazumoto
Middle name
Last name sasaki
Organization Sasaki Medical Hospital,Kazumotokai MedicalCorporation.
Division name Director
Zip code 359-1144
Address 1-7-25 Nishitokorozawa, Tokorozawa-shi, Saitama-ken 359-1144 Japan
TEL 0429-23-7751
Email soumuka@sasaki-memorial.com

Public contact
Name of contact person
1st name Tatsuo
Middle name
Last name Uetake
Organization CXwellness, Inc.
Division name CEO
Zip code 103-0023
Address 516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo,Japan.
TEL 03-6225-5601
Homepage URL
Email uetake@cx-wellness.com

Sponsor
Institute Sasaki Medical Hospital,Kazumotokai MedicalCorporation.
Institute
Department

Funding Source
Organization Kewpie corporation
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 Ueno asagao clinic
Address 2-7-5, Higashiueno, Taito Ku, Tokyo To, 110-0015, Japan
Tel 03-6240-1162
Email info@ueno-asagao.clinic

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
2019 Year 12 Month 12 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 12 Day
Last follow-up date
2019 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044244

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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