Healthy adult
Conditions
Interventions
Food containing plant hishi extract and lutein, once a day for 12 weeks
Placebo without plant hishi extract and lutein, once a day for 12 weeks
Sponsors
TTC Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged from 40 to 55. (2) Subjects with subjective eye fatigue. (3) A higher NPA at screening examination
Exclusion criteria
Exclusion criteria: (1) Subjects who have amblyopia or strabismus. (2) Subjects who are judged as presbyopia (the control width is less than 2.5 D for dominant eye). (3) Subjects who have an uncorrected serious refractive error for dominant eye. (4) Subjects who have undergone ophthalmic surgery for dominant eye. (5) Subjects who have a serious eye disease or history of eye disease. (6) Subjects who have a disease (e.g., pollinosis) which may influence the outcome of the study (7) Subjects who have been taking health foods containing plant hishi extract, lutein, vitamin E for 3 months or expected to use during study. (8) Subjects who have been taking health foods or medicines which may have effects to the amplitude of accommodation (including eye fatigue) for 3 months or expected to use during study (9) Subjects who have been taking health foods or medicines which may have effects to the stiffness of shoulder and neck for 3 months or expected to use during study (10) Subjects who cannot execute a display work load test (11) Subjects who may have allergy to the test foods (12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (13) Subjects who have under treatment of drug addiction and/or alcoholism (14) Subjects who are participating other clinical studies or went back from an agreement acquisition day and participated in other clinical studies within 3 months or who are planning to participate other clinical studies during this study (15) Subjects who are pregnant, breastfeeding, or planning to be pregnant or breastfeeding during study (16) Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value (17) Subjects who are judged as unsuitable for lifestyle questionnaire (18) Subjects who are judged as unsuitable by doctor for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Near point of accommodation (NPA) Evaluate at points of 4-week, 8-week and 12-week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Refractive power , best-corrected visual acuity, questionnaire | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
TTC Co.,Ltd. Clinical Research Planning Department
Outcome results
None listed