The effect of test foods containing plant extracts on cognitive function

UMIN ID: UMIN000054532

Registered date:31/05/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/05/31
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Take two capsules per day of the active food (soft capsules with plant extracts) (24 weeks)
Take two capsules per day of the placebo food (soft capsules without plant extracts) (24 weeks)

Outcome(s)

• Primary Outcome: 1. The measured value of the standardized score of composite memory at 24 weeks after consumption (24w), and the amount and rate of change of it from screening (before consumption; Scr)
• Secondary Outcome: 1. The measured value of the standardized score of composite memory at 12 weeks after intervention (12w), and the amount and rate of change of it from Scr 2. The measured values of the standardized scores of Neurocognition Index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed at 12w and 24w, and the amount and rate of changes of them from Scr 3. The measured value of score in the Japanese version of Montreal Cognitive Assessment (MoCA-J) at 12w and 24w, and the amount and rate of change from Scr 4. The measured value of total score in the self-administered dementia checklist at 12w and 24w, and the amount and rate of change from Scr 5. The measured value of score in the MIRUDAKE at 12w and 24w, and the amount and rate of change from Scr 6. The measured value of score in the CogEvo at 12w and 24w, and the amount and rate of change from Scr 7. The measured value of high sensitivity C-reactive protein (CRP) at 12w and 24w, and the amount and rate of change from Scr

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: Individuals (who/whose) 1. are under treatment or have a history of serious diseases of the heart, liver, kidneys, digestive organs, or others 2. are under treatment or have a history of cardiovascular disease, especially malignant tumor, heart failure, or myocardial infarction 3. have a pacemaker or an implantable cardioverter defibrillator 4. under treatment for any of chronic disease such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, or hypertension 5. have dementia 6. with suspected insomnia 7. are under treatment or have a history of psychiatric disorder (including depressive symptoms) or cerebrovascular disease 8. drink pure alcohol >= 40 g/day (men) or >= 20 g/day (women) 9. are smokers 10. have a disability of both hands by injuries, surgeries, or other reasons 11. have extremely irregular eating habits or irregular lifestyles by shift work, night work, or other reasons 12. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 13. take medicines (including herbal medicines) or supplements, especially antipsychotic, anti-anxiety, antidepressants, anti-Parkinson, antimanic, antiepileptic, or anticoagulant 14. with allergies (medicines or foods related to test products), especially turmeric 15. are pregnant, lactating, or planning to become pregnant during this study 16. enrolled in other studies within 28 days before the agreement to participate or plan to participate other studies during this study 17. donated blood within one month before the agreement to participate in this study 18. donated 400 mL of whole blood within three months (men) or four months (women) before the agreement to participate in this study 19. blood collection volume exceeds 1,200 mL (men) or 800 mL (women) from 12 months before the agreement to participate until completion of this study 20. are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: House Wellness Foods Corporation