Healthy Japanese adults
Conditions
Interventions
Duration: 12 weeks Test food: ONO-SR/AST-SOYPC (containing salmon roe oil, astaxanthin and soy lecithin) Administration: Take four capsules with water without chewing after meals
Duration: 12
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. Men or women aged between 50 and 80 4. Healthy subjects 5. Subjects whose scoring of Mini Mental State Examination (MMSE) is between 24 and 28 6. Subjects who have relatively low standardized score in composite memory measured using Cognitrax 7. Subjects having a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 8. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: Subjects who 1.have a pacemaker or an implantable cardioverter defibrillator 2.have COVID-19 3.have a past medical history (PMH) of malignant tumor, heart failure, and myocardial infarction 4.are undergoing treatment for chronic diseases (e.g. atrial fibrillation, arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, gastrointestinal disorder) 5.have a PMH or current medical history (CMH) of psychosis, dementia, cranial nerve diseases, or cerebrovascular diseases 6.have depressive symptoms/have been diagnosed with depression 7.usually take medicines, herbal medicines, and supplements (Foods for Specified Health Uses, or Foods with Functional Claims) 8.take health foods with rich e.g. DHA, EPA or blue-backed fish (e.g. sardines, mackerel, and saury) at least 4 times a week 9.consecutively take medicines or health foods that may influence the results (e.g. ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, and plasmalogen) at least a week 10.have difficulty performing cognitive tests due to poor eyesight or hearing 11.have a CMH of menopausal symptoms 12.have a PMH or CMH of drug or alcohol dependence 13.will have an irregular life due to e.g. night shifts twice or more during this trial 14.are smokers/have quit smoking within 12 months before the pre-consumption assessment (0w) 15.donated 200 or 400 mL of whole blood/had a blood transfusion within 3 months before 0w 16.are judged as ineligible to participate from laboratory values or measurement at 0w 17.are judged as ineligible to participate from lifestyle questionnaires 18.are allergic to medicines or test food related products 19.have a PMH of atopic dermatitis 20.are pregnant/lactating/will be pregnant during this trial 21.have been enrolled in other clinical trials within 28 days before agreeing to participate or plan to participate another trial during this trial 22.are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The standardized score of composite memory at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The standardized scores of cognitive function tests (except for composite memory) at 12w 2. The Profile of Mood States 2nd Edition (POMS2) at 12w 3. Plasma cortisol at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed