UMIN-ICDS Clinical Trial

Public title

Effect of the Test Food on Cognitive Function in Japanese Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Acronym

Effect of the test food intake on cognitive function in Japanese adults

Scientific Title

Effect of the Test Food on Cognitive Function in Japanese Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Scientific Title:Acronym

Effect of the test food intake on cognitive function in Japanese adults

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of continuous intake of food containing plant extracts for 16 weeks on cognitive function in Japanese male and female aged 40 to under 60 years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Total score for SCD-Q (My-Cog)

Key secondary outcomes

(Secondary outcomes)
Subscale scores of the SCD-Q (My-Cog), total and subscale scores of the SCD-Q (Their-Cog), WMS-R, New Stroop Test II, and EMC, Subgroup analysis.
(Exploratory outcome measures)
Japanese version of the HHIA, CES-D, and biomarker measurement using stored specimens.
(Safety evaluation)
Vital signs, physical measurements(body weight and BMI), biochemical test, hematology test, urinalysis, adverse events.

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

Continuous intake of food containing plant extract for 16 weeks.

Interventions/Control_2

Continuous intake of placebo for 16 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

40

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Japanese males and females aged 40 to under 60 years at the time of written informed consent.
2.Subjects who feel they are experiencing cognitive decline (with a total SCD-Q (My-Cog) score of 7 or higher)
3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.

Key exclusion criteria

1.Subjects with a history of gastrointestinal resection surgery (excluding appendectomy).
2.Subjects with an MMSE score of 27 or lower.
3.Subjects who have been diagnosed with dementia or mild cognitive impairment (MCI).
4.Subjects with a serious illness under treatment or a history of serious disease requiring medication.
5.Subjects with a history of diagnosis or treatment for psychiatric disorders (e.g., depression), or who are considered to have unstable psychiatric symptoms during the study period.
6.Subjects who have been continuously consuming drugs, Foods for Specified Health Uses, Foods with Function Claims, or health foods that may affect study outcomes at least 3 days per week over the past 3 months, and who are unable to discontinue such intake from one month before the baseline examination.
7.Subjects who have a history of or currently receive treatment for cerebrovascular disease (e.g., cerebral/subarachnoid hemorrhage, cerebral infarction/ transient ischemic attacks, cerebral aneurysm, and moyamoya disease), or who had a traumatic injury to the head within the past 10 years.
8.Subjects who have color vision deficiency or hearing impairment that may affect the cognitive function tests or other study assessments.
9.Subjects who have undergone cognitive function tests (e.g., neuropsychological assessments of memory and attention) within the past 12 months.
10.Subjects who have specialized knowledge of the memory and cognitive function tests used in this study.
11.Subjects who are at risk of developing allergic reactions to any study-related procedures or materials.
12.Subjects who intend to become pregnant during the study period, are pregnant (or may be pregnant), or are breastfeeding.
13.Subjects with extremely irregular lifestyles due to night shift work or rotating shift work.
14.Subjects whose lifestyle habits, including eating and sleeping patterns, are extremely irregular.

Target sample size

110

Name of lead principal investigator

1st name	Tomoki
Middle name
Last name	Adachi

Organization

FANCL Corporation

Division name

Research Institute

Zip code

244-0806

Address

12-13 Kamishinano, Totsuka-ku, Yokohama-shi, Kanagawa 244-0806 Japan

TEL

045-820-3846

Email

adachi_tomoki@fancl.co.jp

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Miyazawa

Organization

HUMA R&D CORP

Division name

Clinical Development Department

Zip code

108-0023

Address

NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan

TEL

03-3431-1260

Homepage URL

Email

rd@huma-rd.co.jp

Institute

FANCL Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Corporation DiaStep Ouchinodoctor Research Ethics Committee

Address

Morizumi Bldg. 3F, 4-22-7 Taishido, Setagaya-ku, Tokyo, 154-0004, Japan

Tel

03-5433-3255

Email

tomohisa.kato@diastep.jp

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

2026

Year

05

Month

27

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

05

Month

20

Day

Date of IRB

2026

Year

05

Month

21

Day

Anticipated trial start date

2026

Year

05

Month

28

Day

Last follow-up date

2026

Year

12

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
15.Subjects with heavy alcohol consumption (average daily intake of 60 g of pure alcohol or more).
16.Excessive smokers (average daily consumption of 21 cigarettes or more).
17.Subjects who plan to travel abroad or undertake domestic travel or business trips of 1 week or longer during the study period.
18.Subjects participating in another clinical study at the start of this study.
19.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month, or more than 400 mL within 3 months prior to the date of informed consent.
20.Subjects who are unable to complete study questionnaires.
21.Subjects whose laboratory test values or other examination results at screening indicate that they are ineligible for participation in the study.
22.Subjects who are deemed ineligible for the study by the investigator for any other reasons.

Registered date

2026

Year

05

Month

27

Day

Last modified on

2026

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070596