UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060771 |
|---|---|
| Receipt number | R000069233 |
| Scientific Title | Study on the Effects of Test Food Intake on Cognitive Function --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial-- |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/24 09:20:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the Effects of Test Food Intake on Cognitive Function
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Acronym
Study on the Effects of Test Food Intake on Cognitive Function
Scientific Title
Study on the Effects of Test Food Intake on Cognitive Function
--A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--
Scientific Title:Acronym
Study on the Effects of Test Food Intake on Cognitive Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of consuming the test food on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Stroop Test in the Cognitrax Cognitive Function Assessment
Key secondary outcomes
*Secondary Endpoints
1) Other measures in the Cognitrax cognitive function test
2) SF-36v2 Japanese Standard Version
3) Subjective Questionnaire Survey
4) Antioxidant, cognitive function, and blood concentration-related tests using biological samples
*Safety Evaluation Items
1) Weight/Body Fat Percentage/BMI
2) Blood Pressure/Pulse Rate
3) Hematological Tests
4) Blood Biochemical Tests
5) Urinalysis
6) Physician Interview/Adverse Reaction Occurrence/Adverse Event Assessment
7) Daily Activity Log
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of a test food (2 capsules in a day; 16 weeks).
Interventions/Control_2
Oral ingestion of a placebo food (2 capsules in a day; 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
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 40 to 59 at the time of obtaining consent to participate in the trial.
2) Individuals with normal cognitive function.
3) Individuals who experience stress or fatigue due to work or household duties and perceive a decline in cognitive function (information processing ability, attention, memory, etc.).
4) Individuals with a work habit of five or more days per week.
5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
6) Individuals who can attend the designated examination date and undergo the examination.
7) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing treatment, or individuals using pharmaceuticals.
2) receiving treatment or medication due to dementia, mental illness, or cerebrovascular disease.
3) diagnosed with cerebral infarction, cerebrovascular disease, arteriosclerosis, or circulatory system disease.
4) with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive tract, or mental disorders.
5) exhibiting symptoms of severe anemia.
6) who have taken or applied medications for disease treatment within the past month.
7) with potential cognitive impairment.
8) Individuals unable to respond to the study assessments, including:
a) with difficulty distinguishing colors.
b) with uncorrected or poorly corrected vision impairment.
c) unable to understand the test due to hearing impairment.
d) with limited ability to communicate in Japanese.
e) unable to recognize Arabic numerals.
9) with a BMI of 30.0 kg/m2 or higher.
10) with potential allergies to test food ingredients or other foods/medications.
11) who used cognitive function-related foods or supplements within the past 3 months.
12) who used or plan to use supplements containing test food or result-affecting ingredients within 3 months.
13) with a habit of excessive consumption of beverages high in caffeine.
14) exceeding daily alcohol limits (40 g men, 20 g women).
15) with irregular daily routines.
16) Night shift workers.
17) who may alter their daily routines during the study period.
18) who are pregnant, breastfeeding, or may become pregnant during the trial period.
19) another trial or within the past 3 months.
20) with ties to health/functional food companies.
21) Other individuals deemed ineligible for this trial by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Morikawa |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition SV Supplement Strategic Unit
Zip code
107-6028
Address
1-12-32 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
050-3133-7673
hideyuki.morikawa@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069233
