UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038848 |
|---|---|
| Receipt number | 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 | 2020/08/26 13:31:29 |
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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
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
uetake@cx-wellness.com
Sponsor or person
Institute
Sasaki Medical Hospital,Kazumotokai MedicalCorporation.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044244
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