UMIN-ICDS Clinical Trial

Public title

Verification study of the effects of test food consumption on cognitive function in healthy Japanese

Acronym

Verification study of the effects of test food consumption on cognitive function in healthy Japanese

Scientific Title

Effects of consumption of the test food on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on cognitive function in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on cognitive function in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of verbal memory at 12 weeks after intervention (12w)

Key secondary outcomes

1. The measured values of neurocognition index (NCI), composite memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention, and motor speed at 12w

2. The measured values of growth hormone (GH), insulin-like growth factor-1 (IGF-1), free fatty acids, and cortisol at 12w

3. Individuals who experienced adverse events

4. Individuals whose urinalysis and peripheral blood test values were within the reference range at screening but became outside the reference range after intervention

5. Physical measurements, urinalysis, and peripheral blood test

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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test product: Liquid form containing GPC
Administration: Consume two capsules once with water after dinner or before sleep.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Interventions/Control_2

Duration: 12 weeks
Test product: Liquid form not containing GPC
Administration: Consume two capsules once with water after dinner or before sleep.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

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

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Individuals aged 40 or more

4. Healthy individuals

5. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at screening (Scr)

6. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr

7. Individuals whose standardized score in verbal memory measured using Cognitrax is less than 100 at Scr

Key exclusion criteria

Individuals (who / whose)
1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. have an implanted pacemaker or implantable cardioverter defibrillator

3. are currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. consume Foods for Specified Health Uses or Foods with Functional Claims

5. are taking or using medications (including herbal medicines) or supplements

6. are allergic to medications or foods related to the test product

7. have dementia

8. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

9. regularly consume foods with rich procyanidins (such as apple, black soybean, or cacao)

10. usually take supplements or foods that may be related to improving cognitive functions, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, and plasmalogen

11. take blue-backed fish such as sardines, mackerel, and saury at least four times a week

12. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)

13. have irregular sleeping time or habit due to work such as a late-night shift

14. currently smoke or began smoking cessation within three months before providing informed consent

15. habitually drink more than 60 g/day of alcohol

16. are pregnant, lactating, or planning pregnancy during this study

17. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

18. are deemed unsuitable for participation in this study by the principal investigator

Target sample size

56

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

Claudia Co., Ltd.

Institute

Department

Personal name

Organization

Claudia Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2026

Year

09

Month

30

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

Open public recruiting

Date of protocol fixation

2026

Year

09

Month

09

Day

Date of IRB

2026

Year

09

Month

09

Day

Anticipated trial start date

2026

Year

09

Month

30

Day

Last follow-up date

2027

Year

04

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

30

Day

Last modified on

2026

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072255