UMIN-CTR Clinical Trial

Public title

A Study on cognitive function improving effect for adult healthy men and women

Acronym

A Study on cognitive function improving effect for adult healthy men and women

Scientific Title

A Study on cognitive function improving effect for adult healthy men and women

Scientific Title:Acronym

A Study on cognitive function improving effect for adult healthy men and women

Region

Japan

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of intake of a test food on cognitive function

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Tests for memory functions

Key secondary outcomes

Tests for memory functions
Tests for attention functions
Tests for executive functions
Questionnaires

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of a test food for 20 consecutive weeks

Interventions/Control_2

Ingestion of placebo for 20 consecutive 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

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Male and female aged 50 and older
2) Subjects with self-awareness of forgetfulness but who are judged healthy by a doctor
3) Subjects with inferior scores of cognitive function tests

Key exclusion criteria

1) Subjects who are difficult to discriminate color
2) Subjects with bad eyesight, or are diagnosed with amblyopia or blindness
3) Subjects with bad hearing, or are diagnosed with hearing loss or permanent hearing loss
4) Subjects with history of cranial nerve disease
5) Subjects who are under treatment of cognitive functions, or are prescribed with medicine for them
6) Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
7) Subjects who diagnosed with dementia or MCI by a doctor at screening test
8) Subjects who are under hormone treatment or are diagnosed with menopause
9) Subjects who have a pain or disease at wrist or arm
10) Subjects who have some irregular schedules during the study, due to night work or something
11) Subjects who drink much alcohol
12) Subjects who smoke, or quit smoking within one year before screening test
13) Subjects who have done the same cognitive function test within one year before screening test
14) Subjects who continuously take medicine, health foods, Food for Specified Health Uses or Foods with Function Claims including substance related to cognitive functions
15) Subjects who was given or donated 200 mL or 400 mL of whole blood within three months before screening test
16) Subjects who participated in other study within one month before screening test, or are going to participate in other study during the study
17) Subjects who have a disease which needs regular medication, or have a history of the disease
18) Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in screening test
19) Subjects who are in danger of allergy to the study
20) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
21) Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
22) Subjects who are judged as unsuitable for the study by investigator for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuya Hirata

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Division name

Healthcare Division

Zip code

Address

1-30-3, Toyokawa, Ibaraki-city, Osaka

TEL

072-640-0131

Email

t.hirata@kobayashi.co.jp

Name of contact person

1st name
Middle name
Last name	Takashi Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

t.nakagawa@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2017

Year

10

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

15

Day

Last modified on

2018

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033775