Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Drink containing beta-hydroxybutyric acid (BHB) (BHB 16.0 g/day) Administration: Drink four bottles after breakfast and four bottles before going to bed * Daily dose
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who are aware of the decline in their memory function 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have 24 points or more of MMSE (Mini Mental State Examination) 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have a relatively low standardized score in composite memory by Cognitrax
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who have dementia 5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 6. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 7. Subjects who take supplements or foods that may be 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 in daily use 8. Subjects who take blue-backed fish such as sardines, mackerel, and saury at least four times a week 9. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily 10. Subjects currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, breast-feeding, and planning to become pregnant 13. Subjects who suffer from COVID-19 14. Subjects who 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 15. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy Outcome 1-1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy Outcomes 1-1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w 1-2. The measured value 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} at four weeks after consumption (4w) and 12w 1-3. The amount of change of the standardized score of each cognitive domain from Scr to 4w and 12w 1-4. The measured values of each of the items of an original qustionaires at 4w and 12w 2. Safety Outcomes 2-1. Incidence of side effects 2-2. Incidence of adverse events 2-3. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Scr 2-4. Physical measurement 2-5. Urinalysis 2-6. Blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed