UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059319 |
|---|---|
| Receipt number | R000067735 |
| Scientific Title | A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/07 16:34:37 |
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Basic information
Public title
A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen
Acronym
A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen
Scientific Title
A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen
Scientific Title:Acronym
A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects on cognitive function improvement, mood improvement, vanillylmandelic acid, and homovanillic acid concentrations in urine after consuming the test food for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States 2nd Edition, Adult Version - Full Item Set
Uchida-Kraepelin performance test
Key secondary outcomes
Urine test (vanillylmandelic acid, homovanillic acid)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 1 capsule containing test food after dinner, for 8 weeks.
Interventions/Control_2
Intake 1 capsule containing no test food after dinner, for 8 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 30 years or older but under 60 years at the time of consent acquisition
(2) Individuals scoring 50 points or higher on any of the following POMS2 paper-based subscales: Anger-Hostility (AH), Confusion-Bafflement (CB), Depression-Downcast (DD), Fatigue-Inertia (FI), or Tension-Anxiety (TA)
(3) Individuals who have received prior explanation of the clinical trial and can provide written informed consent
Key exclusion criteria
(1) Individuals taking medications that may affect test results (e.g., antipsychotics, anxiolytics, antidepressants, antiparkinsonian drugs, antipsychotics, antiepileptics, anticoagulants, etc.)
(2) Individuals regularly consuming specific health foods, foods with functional claims, or other so-called health supplements (e.g., foods claiming effects on cognitive function, stress relief, sleep improvement, etc.) that may affect test results
(3) Individuals who have been hospitalized for treatment or undergone surgery due to cerebral infarction, cerebrovascular disease, cerebral contusion, or head injury
(4) Individuals with a past or current history of serious conditions that could affect the trial, such as epileptic seizures, psychosis, or dementia
(5) Individuals who habitually consume excessive amounts of tobacco or alcohol
(6) Individuals with extremely irregular eating habits, or those with irregular daily rhythms such as shift workers or night workers
(7) Individuals who have undergone neuropsychological testing within a hospital setting
(8) Individuals with allergies to pharmaceuticals or foods
(9) Pregnant individuals, breastfeeding individuals, or individuals planning to become pregnant during the trial period
(10) Individuals currently participating in another clinical trial for a drug or health supplement, within 4 weeks of completing such a trial, or planning to participate in another clinical trial after giving consent for this trial
(11) Individuals deemed unsuitable for participation in this trial by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kotoura |
Organization
Marudai Food Co.,Ltd.
Division name
CENTRAL RESEARCH INSTITUTE
Zip code
569-8577
Address
21-3, Midori-Cho, Takatsuki-Shi, Osaka, 569-8577,JAPAN
TEL
072-661-2552
kotoura_satoshi@marudai.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Todoriki |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
MARUDAI FOOD CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
MARUDAI FOOD CO., LTD.
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
Matsumoto Health Lab
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
Tel
0263-39-1139
info@m-health-lab.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
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067735
