NIPH Clinical Trials Search

Effects of consumption of the test food on the cognitive function in healthy Japanese subjects

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy Japanese subjects
Date of first enrollment	2023/06/07
Target sample size	60
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Duration: 12 weeks Test food: Coffee cherry pulp extract (low amount) Duration: 12 weeks Test food: Coffee cherry pulp extract (high amount) Duration: 12 weeks Test food: Dextrin powder

Outcome(s)

Primary Outcome

1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w)

Secondary Outcome

1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w 2. The measured values and the amount of changes from Scr of the standardized scores of each cognitive domain {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}, Mini Mental State Examination (MMSE) score, and brain derived neurotrophic factor (BDNF) at 12w

Key inclusion & exclusion criteria

Age minimum	40years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	Subjects (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products 7. are pregnant, lactating, or planning to become pregnant during this trial 8. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. have dementia 10. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 11. take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen 12. take blue-backed fish such as sardines, mackerel, and saury at least four times a week 13. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 14. sleeping time or habit is irregular due to work such as a late-night shift 15. amount of smoking varies widely from day to day 16. alcohol intake varies widely from day to day 17. have irregular lifestyles (such as diet, exercise, and sleep) 18. have caffeine sensitivity 19. take beverages with rich caffeine, such as coffee or energy drink in daily 20. are judged as ineligible to participate in this study by the physician