None listed
Conditions
Interventions
Oral ingestion of a test food (2 capsules in a day
16 weeks).
Oral ingestion of a placebo food (2 capsules in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy men and women aged 40 to 59 at the time of obtaining consent to participate in the trial. 2) Individuals with normal cognitive function. 3) Individuals who experience stress or fatigue due to work or household duties and perceive a decline in cognitive function (information processing ability, attention, memory, etc.). 4) Individuals with a work habit of five or more days per week. 5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial. 6) Individuals who can attend the designated examination date and undergo the examination. 7) Individuals deemed suitable for participation in this trial by the principal investigator.
Exclusion criteria
Exclusion criteria: Individuals 1) currently suffering from any disease and undergoing treatment, or individuals using pharmaceuticals. 2) receiving treatment or medication due to dementia, mental illness, or cerebrovascular disease. 3) diagnosed with cerebral infarction, cerebrovascular disease, arteriosclerosis, or circulatory system disease. 4) with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive tract, or mental disorders. 5) exhibiting symptoms of severe anemia. 6) who have taken or applied medications for disease treatment within the past month. 7) with potential cognitive impairment. 8) Individuals unable to respond to the study assessments, including: a) with difficulty distinguishing colors. b) with uncorrected or poorly corrected vision impairment. c) unable to understand the test due to hearing impairment. d) with limited ability to communicate in Japanese. e) unable to recognize Arabic numerals. 9) with a BMI of 30.0 kg/m2 or higher. 10) with potential allergies to test food ingredients or other foods/medications. 11) who used cognitive function-related foods or supplements within the past 3 months. 12) who used or plan to use supplements containing test food or result-affecting ingredients within 3 months. 13) with a habit of excessive consumption of beverages high in caffeine. 14) exceeding daily alcohol limits (40 g men, 20 g women). 15) with irregular daily routines. 16) Night shift workers. 17) who may alter their daily routines during the study period. 18) who are pregnant, breastfeeding, or may become pregnant during the trial period. 19) another trial or within the past 3 months. 20) with ties to health/functional food companies. 21) Other individuals deemed ineligible for this trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Stroop Test in the Cognitrax Cognitive Function Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary Endpoints 1) Other measures in the Cognitrax cognitive function test 2) SF-36v2 Japanese Standard Version 3) Subjective Questionnaire Survey 4) Antioxidant, cognitive function, and blood concentration-related tests using biological samples *Safety Evaluation Items 1) Weight/Body Fat Percentage/BMI 2) Blood Pressure/Pulse Rate 3) Hematological Tests 4) Blood Biochemical Tests 5) Urinalysis 6) Physician Interview/Adverse Reaction Occurrence/Adverse Event Assessment 7) Daily Activity Log | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed