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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047738
Receipt No. 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 2022/05/12

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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
Email 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
Email yumi_takeda@kewpie.co.jp

Sponsor
Institute Kewpie Corporation
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 Ethics Committee of Ueno-Asagao Clinic
Address 2-7-5, Higashiueno, Taito-ku, Tokyo
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
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 Enrolling by invitation
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
2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054424

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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