UMIN-ICDS Clinical Trial

Public title

Effects of consumption of the test food on attention: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Acronym

Effects of consumption of the test food on attention: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title

Effects of consumption of the test food on attention: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on attention

Region

Japan

Condition

Healthy adults

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 attention in healthy adults.

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 the standardized score of complex attention on Cognitrax at 8 weeks after consumption (8w)

Key secondary outcomes

1. The changes and percentage changes of the standardized scores of complex attention on Cognitrax from screening (Scr) at 8w

2. The measured values of the standardized scores of each cognitive domain {neurocognition index (NCI), complex attention, verbal memory, visual memory, psychomotor speed, reaction time, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed} on Cognitrax, and the changes and percentage changes of them from Scr

3. The measured values of inattention / memory problems, hyperactivity/restlessness, impulsivity/emotional lability, problems with self-concept, Diagnostic and Statistical manual of Mental disorders-IV (DSM-IV) inattentive-type symptoms, DSM-IV hyperactive-impulsive-type symptoms, DSM-IV attention-deficit hyperactivity disorder (ADHD) symptoms total, and ADHD index of the Conners' Adult ADHD Rating Scales (CAARS), and the changes and percentage changes of them from Scr

4. Individuals whose responses to each item in the CAARS improved by one or more scales at 8w

5. The measured values of the Autism-spectrum Quotient (AQ) score, social skill, attention switching, attention to detail, communication, and imagination of the AQ, and the changes and percentage changes of them from Scr

6. Individuals whose responses to each item in the AQ improved by one or more scales at 8w

7. Individuals who experienced adverse events

8. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr

9. 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: 8 weeks
Test product: Product containing water soluble polyphenol
Administration:
Consume one tablet three times daily (breakfast, lunch, or dinner, in total three tablets a day) with water.
*If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.

Interventions/Control_2

Duration: 8 weeks
Test product: Product not containing polyphenol
Administration:
Consume one tablet three times daily (breakfast, lunch, or dinner, in total three tablets a day) with water.
*If a take is missed, it should be consumed as soon as remembered. The daily take 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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose total score of the Mini Mental State Examination-Japanese (MMSE-J) is 24 or more at Scr

6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory-II (BDI-II) at Scr

7. Individuals who are judged not to have an autism spectrum disorder including high-functioning autism or Asperger's syndrome, based on their responses to the Japanese version of the AQ at Scr

8. Individuals who are judged not to have ADHD based on their responses to the Japanese version of the CAARS at Scr

9. Individuals whose validity indicator for complex attention on Cognitrax is "Yes" at Scr

10. Individuals whose standardized score of complex attention on Cognitrax is < 100 at Scr

Key exclusion criteria

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

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who 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. Individuals who have dementia or a history of psychiatric disorders, such as depression disorder or ADHD

5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

6. Individuals who are taking or using medications (including herbal medicines) or supplements

7. Individuals who regularly consume foods or supplements that may affect cognitive function, such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA)

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

9. Individuals who use tools, devices, or applications that may affect cognitive function

10. Individuals who are allergic to medications or foods related to the test product

11. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles

12. Individuals who currently smoke or began smoking cessation within three months before providing informed consent

13. Individuals who habitually drink >= 60 g/day of alcohol

14. Individuals who are pregnant, lactating, or planning pregnancy during this study

15. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Target sample size

60

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

Toyo Sugar Refining Co., Ltd.

Institute

Department

Personal name

Organization

Toyo Sugar Refining 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

06

Month

23

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

05

Month

13

Day

Date of IRB

2026

Year

05

Month

13

Day

Anticipated trial start date

2026

Year

06

Month

23

Day

Last follow-up date

2026

Year

12

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

06

Month

23

Day

Last modified on

2026

Year

06

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070970