Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing fermented Ganoderma lucidum and rosemary extract Administration: Take two packets with water without chewing at any time during the day * Daily dos
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 whose scoring of Mini Mental State Examinination (MMSE) is 24 or more at Scr 7. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 8. Subjects whose the standardized score of composite memory measured by Cognitrax are relatively low
Exclusion criteria
Exclusion criteria: Subjects (who) 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 3.currently undergoing treatment for any of the following chronic disease: 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.currently taking medications (including herbal medicines) and supplements 6.are allergic to medicines and/or the test food related products 7.are pregnant, lactation, or planning to become pregnant 8.suffer from COVID-19 9.have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate in another trial during this trial 10.are judged as ineligible to participate in the study by the physician 11.have irregular working hours 12.have irregular ifestyles (such as diet, exercise, and sleep) 13.live with requiring long-term care persons 14.drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 15.take food/beverage containing functional ingredients which may influence cognitive function or vessel function 16.have dementia 17.have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 18.are smokers 19.currently undergoing treatment for hemorrhagic disease, hypotension, thrombocytopenia, convulsive disorder, bradycardia, pulmonary disease, gastrointestinal tract obstruction, peptic ulcer, hyperthyroidism, or urogenital obstruction 20.plan to have surgery within two weeks after this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The standardized score of composite memory | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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} 2. Flow mediated dilation (FMD), maximum expansion width of the blood vessel*, and the resting vessel diameter 3. Vascular age, deviation value of vascular aging, waveform index, and low frequency / high frequency ratio 4. An original questionnaire (1."Are you told that you say the same thing repeatedly by people around you?", 2."Do you often forget where you put your things such as your wallet and keys and have to look for them?", 3."Do you sometimes find it difficult to say the words that you were going to say?", 4."Do you feel decline in attention and/or concentration?", 5."Do you sometimes find it difficult to show interest in new things due to lack of motivation?", 6."Do you sometimes forget other things to do while you are doing one thing?", 7. "Can you recall recent news or events and tell it somebody", 8."Do you sometimes lose the plot of a story during a conversation?", 9."Do you feel that you become more angry and/or suspicious easily?", 10."Do you feel that you make more mistakes in daily life such as cooking, cleaning up, calculating, or driving?", 11."Do you feel that you take more time to remember new things / you cannot remember new things / you forget it immediately?", and 12."Do you often feel that you cannot recall people's names?" *Maximum expansion width of the blood vessel = the maximum dilated vessel diameter - the resting vessel diameter | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed