UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036896
Receipt number R000042047
Scientific Title Effects of a Test Food for Cognitive Function (2)
Date of disclosure of the study information 2019/06/20
Last modified on 2023/10/24 15:13:14

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Basic information

Public title

Effects of a Test Food for Cognitive Function (2)

Acronym

Effects of a Test Food for Cognitive Function (2)

Scientific Title

Effects of a Test Food for Cognitive Function (2)

Scientific Title:Acronym

Effects of a Test Food for Cognitive Function (2)

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine effects of a test food for cognitive function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Japanese version of the CNS Vital Signs (Cognitrax)

Key secondary outcomes

Hearing physical condition


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Treatment

Type of intervention

Food

Interventions/Control_1

Single oral ingestion of the test food (once)

Interventions/Control_2

Single oral ingestion of the placebo food (once)

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

1)Japanese individuals aged 20-39 years.
2)Individuals who are healthy and are not suffered from a chronic malady.
3)Individuals whose written informed consent has been obtained.
4)Individulals who can visit an inspection facility and be inspected in designated days.
5)Individuals judged appropriate for the study by the principal.

Key exclusion criteria

1)Individuals using medical products.
2)Individuals with dementia.
3)Individuals who used a drug for treatment of disease in the past 1 month.
4)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
5)Individuals who contract or have a history of serious gastrointestinal disease.
6)Individuals with serious anemia.
7)Individuals who contract or have a history of food allergy. (In particular, milk)
8)Females who are or are possibly pregnant, or are lactating.
9)Individuals who have an addiction to alcohol or a mental illness.
10)Individuals who are a smoker.
11)Individuals whose life style will change during the test period.
12)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense)
13)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
14)Individuals who had a habit to ingest foods claiming to improve cognitive function, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
15)Individuals who have a habit to use drug claiming to improve cognitive function in the past 3 months.
16)Individuals who conducted hormone replacement therapy in the past 6 months or have a history of conducting hormone replacement therapy.
17)Individuals who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period.
18)Individuals who participated in other clinical studies in the past 1 months.
19)Individuals judged inappropriate for the study by the principal.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Minoru
Middle name
Last name Morita

Organization

Morinaga & Co.,Ltd

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Email

m-morita-je@morinaga.co.jp


Public contact

Name of contact person

1st name Sadao
Middle name
Last name Mori

Organization

MORINAGA & CO., LTD.

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Homepage URL


Email

s-mori-ab@morinaga.co.jp


Sponsor or person

Institute

MORINAGA & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

MORINAGA & CO., LTD.

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

Japan Aesthetic Dermatology Symposium

Address

15-1-604,Himonya 5-Chome,Meguro-ku,Tokyo,Japan

Tel

03-3794-1235

Email

info@jp-ads.com


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 06 Month 20 Day


Related information

URL releasing protocol

Jpn Pharmacol Ther vol.47, no.10, 1655-1664 2019

Publication of results

Published


Result

URL related to results and publications

Jpn Pharmacol Ther vol.47, no.10, 1655-1664 2019

Number of participants that the trial has enrolled

15

Results

Jpn Pharmacol Ther vol.47, no.10, 1655-1664 2019

Results date posted

2023 Year 10 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Jpn Pharmacol Ther vol.47, no.10, 1655-1664 2019

Participant flow

Jpn Pharmacol Ther vol.47, no.10, 1655-1664 2019

Adverse events

None

Outcome measures

Cognitrax

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 06 Month 07 Day

Date of IRB

2019 Year 06 Month 05 Day

Anticipated trial start date

2019 Year 06 Month 10 Day

Last follow-up date

2019 Year 07 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2019 Year 05 Month 30 Day

Last modified on

2023 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042047


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name