Healthy adult
Conditions
Interventions
Intake the research food once a day, 1 piece for 8 consecutive weeks
Intake the placebo once a day, 1 piece for 8 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Working generation males and females of from 20 to 64 years of age (2) Subjects who are dissatisfied with their sleep and aware of fatigue, and feel a decline in their performance (concentration, attention, etc.) in their daily lives (3) Subjects who have relatively low Cognitrax attention scores at the pre-test. (4) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: (1) Subjects who have difficulty distinguishing colors (2) Subjects who suspected of having dementia (3) Subjects who have difficulty in evaluating cognitive function tests (4) Subjects who suspected of having depression/major depressive disorder (5) Subjects whose sleeping environment, bedtime, and wake-up time are irregular during the study period (6) Subjects who engaged in manual labor such as transporting heavy objects (7) Subjects who have nocturia, benign prostatic hyperplasia, or overactive bladder (8) Subjects who engage in activities that affect cognitive function, sleep, fatigue, concentration, or attention (9) Subjects who are using medicines that affect cognitive function, sleep, fatigue, concentration, and attention (10) Subjects who are currently taking health foods related to cognitive function, sleep, fatigue, concentration, and attention, as well as those who plan to take them (11) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study (12) Subjects who may develop allergies in relation to the study (13) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication, and those who are scheduled for surgery (14) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range (15) Subjects who work in shifts, work late at night, and have an irregular daily rhythm (16) Subjects who are participating in the other study at the start of this study (17) Subjects who plan to become pregnant or breastfeed during the study period (18) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey (19) Subjects who are judged as unsuitable for the study by the principal investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MIREVO, Cognitrax long | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA-MA, SMH, Fatigue VAS, POMS2 | — |
Countries
Japan
Contacts
Public ContactRio Fujiwara
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed