UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047738 |
|---|---|
| Receipt number | R000054424 |
| Scientific Title | A preliminary study on the effect of a containing egg-derived ingredients intake on cognitive function |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2023/02/06 09:33:52 |
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Basic information
Public title
A preliminary study on the effect of a containing egg-derived ingredients intake on cognitive function
Acronym
A preliminary study on the effect of a containing egg-derived ingredients intake on cognitive function
Scientific Title
A preliminary study on the effect of a containing egg-derived ingredients intake on cognitive function
Scientific Title:Acronym
A preliminary study on the effect of a containing egg-derived ingredients intake on cognitive function
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of consumption of foods containing egg-derived ingredients on cognitive function.
In addition, we will evaluate the association between egg-derived ingredient intake and cognitive function at baseline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food for 12 weeks.
Interventions/Control_2
Intake the Placebo food for 12 weeks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Kewpie Group employees who voluntarily wish to participate in the study and provide written consent
(ii) Males and females aged 20 to 65 years who are considered healthy and are not being treated for any disease
(iii) Those who can maintain a certain daily lifestyle during the study period
(iv) Those who can provide the results of medical examinations.
Key exclusion criteria
Those with serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness
(2) Those who fall under the judgment category of "D" (medical care required) according to the judgment classification of the Society of Medical Checkups for Human Diseases.
(iii) Those who may have food allergy or drug allergy to the test food
(iv) Those who are otherwise ineligible by the investigator to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7760
Homepage URL
yumi_takeda@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
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
Ethics Committee of Ueno-Asagao Clinic
Address
2-7-5, Higashiueno, Taito-ku, Tokyo
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
| 2022 | Year | 05 | Month | 16 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 14 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054424
