Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059319) titled 'A Parallel-Group Comparative Study on Cognitive Function and Mood State by taking Chicken Breast Plasmalogen' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - MARUDAI FOOD CO., LTD.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 30
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 Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 07 Day
Anticipated trial start date - 2025 Year 11 Month 04 Day
Last follow-up date - 2026 Year 03 Month 16 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067735
Disclaimer: Curated by HT Syndication.
