UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2019 Year 11 Month 27 Day
Date of IRB	2019 Year 11 Month 27 Day
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	2020 Year 08 Month 26 Day

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