UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036999
Receipt number R000042155
Scientific Title Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement
Date of disclosure of the study information 2020/06/05
Last modified on 2019/06/07 18:52:48

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Basic information

Public title

Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement

Acronym

Improvement of cognitive function by Phosphatidylserine

Scientific Title

Improvement of cognitive function by ingestion of Phosphatidylserine containing supplement

Scientific Title:Acronym

Improvement of cognitive function by Phosphatidylserine

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To inspect the improvement effect of the cognitive function by taking of Phosphatidylserine containing supplement for 6 weeks

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluate cognitive function using Mini Mental State Examination (MMSE)

Key secondary outcomes

Standard verbal paired-associate learning test, Benton visual retention test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 3 tablets of Phosphatidylserine-containing supplement daily for 6 weeks

Interventions/Control_2

Take 3 placebo tablets daily for 6 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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)persons who is 60 years old or older
(2)persons who is generally judged as healthy
(3)persons who can give voluntary written consent to participate in the present trial

Key exclusion criteria

(1)persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2)persons who have changed their habitats to take supplements within past 4 weeks.
(3)persons who work in night shift or in day and night shift
(4)persons who have been treated their illness or prevention in a clinic at their informed consent
(5)persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6)persons with the medical histories of alcoholism or drug dependence
(7)persons who might be developed allergic reaction to foods.
(8)persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9)persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10)persons who will not be judged suitable to the participants by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Koichiro
Middle name
Last name Ohnuki

Organization

Faculty of Humanity-Oriented Science and Engineering, Kindai University

Division name

Food Functional Science Laboratory

Zip code

820-0011

Address

11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan

TEL

0948-22-5655

Email

ohnuki@fuk.kindai.ac.jp


Public contact

Name of contact person

1st name Ohnuki
Middle name
Last name Koichiro

Organization

Faculty of Humanity-Oriented Science and Engineering, Kindai University

Division name

Food Functional Science Laboratory

Zip code

820-0011

Address

11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan

TEL

0948-22-5655

Homepage URL


Email

ohnuki@fuk.kindai.ac.jp


Sponsor or person

Institute

Faculty of Humanity-Oriented Science and Engineering, Kindai University

Institute

Department

Personal name



Funding Source

Organization

Japan Outgoing Integrated Medical Association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kinki University Faculty of Industrial Science and Technology Ethics Committee

Address

11-6,Kayanomori,Iizuka-shi, Fukuoka, Japan

Tel

0948-22-5655

Email

ohnuki@fuk.kindai.ac.jp


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

一般社団法人機能性天然物研究機構(福岡県)
General Corporate Judicial Person Functional Natural Products Research Organization(Fukuoka,Japan)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 05 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

Preinitiation

Date of protocol fixation

2019 Year 06 Month 03 Day

Date of IRB


Anticipated trial start date

2019 Year 06 Month 07 Day

Last follow-up date

2019 Year 06 Month 10 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 06 Month 07 Day

Last modified on

2019 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name