UMIN-ICDS Clinical Trial

Public title

Effects of Continuous Test Food Intake on Concentration: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study

Acronym

Effects of Continuous Test Food Intake on Concentration

Scientific Title

Effects of Continuous Test Food Intake on Concentration: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study

Scientific Title:Acronym

Effects of Continuous Test Food Intake on Concentration

Region

Japan

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of 12-week continuous intake of the test food on concentration, a randomized, double-blind, placebo-controlled, parallel-group trial will be conducted in healthy males and females aged 20 to under 65 years who subjectively feel a decline in concentration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cognitive function test (Cognitrax)

Key secondary outcomes

(1) VAS questionnaire
(2) EEG indices
(3) Uchida-Kraepelin test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of test food

Interventions/Control_2

12-week intake of placebo food

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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese male and female individuals aged 20 years or older and under 65 years at the time of providing informed consent.
2. Individuals who subjectively feel a decline in concentration.
3. Individuals who have received sufficient explanation of the study, have the capacity to provide informed consent, fully understand the study, and are able to provide electronic informed consent.

Key exclusion criteria

1. Having psychiatric disorders or sleep disorders with medical treatment/medication, or severe history thereof.
2. Having chronic diseases with medical treatment/medication.
3. A history of severe cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine diseases.
4. Severe history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, bowel resection; excluding simple appendectomy).
5. Regular use of drugs that affect bowel movements.
6. Suspected dementia judged by the principal investigator via subjective cognitive check.
7. Risk of allergy to the test food.
8. Difficulty completing Cognitrax.
9. Difficulty undergoing EEG.
10. Unable to discontinue fermented milk or lactic acid drinks during the study.
11. Unable to discontinue FOSHU, foods with function claims, health foods, or supplements during the study.
12. Current smokers.
13. Habitual alcohol drinkers (approx. 60 g or more alcohol per day).
14. Extremely irregular sleep/diet habits (shift/night workers) or engaged in heavy manual labor.
15. Potential major changes in living environment, diet, or exercise during the trial.
16. Women who are breastfeeding, pregnant, potentially pregnant, or planning pregnancy.
17. Current, recent (within 4 weeks prior to web screening), or scheduled participation in other clinical studies.
18. Judged ineligible by the principal investigator.

Target sample size

220

Name of lead principal investigator

1st name	Soma
Middle name
Last name	Ode

Organization

Macromill Carenet, Inc.

Division name

Clinical Research Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-7108

Email

umin_info@macromillcarenet.jp

Name of contact person

1st name	Ayumi
Middle name
Last name	Sugioka

Organization

Macromill Carenet, Inc.

Division name

Clinical Research Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-7108

Homepage URL

Email

umin_info@macromillcarenet.jp

Institute

Macromill Carenet, Inc.

Institute

Department

Personal name

Organization

Nissin York Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

311-2 Gokan-machi, Maebashi-shi, Gumma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団曙光会コンフォガーデンクリニック（東京）

Date of disclosure of the study information

2026

Year

11

Month

11

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

Preinitiation

Date of protocol fixation

2026

Year

11

Month

05

Day

Date of IRB

2026

Year

11

Month

05

Day

Anticipated trial start date

2026

Year

11

Month

11

Day

Last follow-up date

2027

Year

05

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

10

Day

Last modified on

2026

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072752