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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name