N/A(healthy adults)
Conditions
Interventions
16 weeks)
Oral intake of the placebo product (4 capsules one time in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females aged 40-69 years. 2)Individuals being healthy and are not suffered from a chronic malady. 3)Individuals having healthy cognitive function. 4)Individuals having self-awareness of forgetfulness or whose forgetfulness have been indicated by others. 5)Individuals whose written informed consent has been obtained. 6)Individuals who can come to the designated venue for this study and be inspected. 7)Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1)Individuals using medical products. 2)Individuals using a drug to treat a disease. 3)Individuals having cognitive impairment or mild cognitive impairment. 4)Individuals having visually impairment or hearing impairment. 5)Individuals who used psychotropic drugs in the past 1 month. 6)Individuals having a history of surgery for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, head trauma. 7)Individuals being patient or have a history of hypertension, hyperlipidemia and diabetes. 8)Individuals being patient or have a history of heart failure, kidney failure, and hepatitis B or C. 9)Individuals being patient or have a history of serious hepatopathy, kidney damage, heart disease, lung disease and hematological disease. 10)Individuals being a patient or have a history of endocrine disease. 11)Individuals whose BMI is over 30 kg/m2. 12)Individuals taking alcohol excessively (expressed in an amount of alcohol: over 60g/day). 13)Individuals whose average number of cigarettes for smoking is over 21/day. 14)Individuals with serious anemia. 15)Individuals being sensitive to test product or other foods, and medical products. 16)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with similar efficacy to test product in the past 3 months or will ingest those foods during the test period. 17)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing active ingredient of the test product in the past 3 months or will ingest those foods during the test period. 18)Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. 19)Individuals who participated in other clinical studies in the past 3 months. 20)Individuals being or whose family is engaged in healthy or functional foods. 21)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wechsler Memory Scale-Revised (Week 0, Week 16) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]SF-36v2, Japanese version (Week 0, Week 8, Week 16) [2]Questionnaire of physical feeling (Week 8, Week 16) *Safety evaluation [1]Blood pressure, pulsation (Week 0, Week 8, Week 16) [2]Weight, body fat percentage, BMI (Week 0, Week 8, Week 16) [3]Doctor's questions (Week 0, Week 8, Week 16) [4]Subject's diary (each day during the test period) *Other index [1]Mini Mental State Examination (Week 0) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed