Healthy adults
Conditions
Interventions
Food Constituent derived from microorganism, once a day for 8 weeks
Placebo not containing food Constituent derived from microorganism, once a day for 8 weeks
Sponsors
TTC Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Men and women aged from 35 to 45. (2)Subjects with subjective eye fatigue. (3)Individuals who do the VDT works more than 6 hours a day for more than 1 year. (4)Individuals giving written informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. (5)Subjects who are judged suitable for this study by the investigator.
Exclusion criteria
Exclusion criteria: 1 Subjects who have amblyopia or strabismus 2 Subjects who are judged as presbyopia (the control width is less than 2.5D 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 Best-corrected visual acuity<1.0 for dominant eye 6 Subjects who have a serious eye disease or history of eye disease 7 Subjects who are under treatment of some chronic disease and use medicines or medical supplies continuously 8 Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease) thyroid gland disease, adrenal gland disease, digestive system disease and/or metabolic disorder 9 Subjects who can't stop food similar to test foods or take drugs, health foods 10 Subjects with excessive alcohol-drinking behaviors 11 Subjects who regularly take drugs or health foods which may have effects to the eyes or expected to use during study 12 Subjects who can't stop take drugs or health foods which may have effects to immune functions 13 Subjects having allergy to food or medicine 14 Subjects who can't stop drinking for 2 days until the pre-check day and check days 15 Subjects who have a history of pollinosis 16 Subjects who have tendency to get diarrhea by eating dairy product 17 Subjects who have under treatment or a history of drug addiction and/or alcoholism 18 Subjects who and whose family work in a company developing or manufacturing functional foods 19 Subjects who can't execute a display work load test 20 Subjects who are participating or willing to participate in other clinical trials or in the last 3 months 21 Subjects who are or plan to be pregnant, breastfeeding during study 22 Subjects who are judged as unsuitable by doctor for anthropometric measurements or physical examination value 23 Subjects who are judged as unsuitable for lifestyle questionnaire 24 Subjects who are judged as unsuitable by doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast sensitivity, Critical flicker frequency, visual analogue scale. Evaluate at points of 4-week and 8-week. | — |
Secondary
| Measure | Time frame |
|---|---|
| refract, best-corrected visual acuity, ear point distance (amplitude of accommodation), schirmer's test, DEQS | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
TTC Co.,Ltd. Clinical Research Planning Department
Outcome results
None listed