Effect of Test Food Consumption on Visual Function.
- Conditions
- o
- Registration Number
- JPRN-UMIN000048895
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
[1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals who used a drug to treat a disease in the past 1 month. [6] Individuals who use artificial tears more than 6 times a day in everyday life. [7] Individuals who have been diagnosed with presbyopia or are aware of presbyopia. [8] Individuals with eye diseases, entropion, or trichiasis. [9] Individuals with a confirmed diagnosis of dry eye. [10] Individuals who are using eye drops for the treatment of ocular diseases. [11] Individuals who have refractive errors and have not been properly corrected. [12] Individuals who have undergone LASIK vision restoration surgery. [13] Individuals with high intensity astigmatism. [14] Individuals whose eye fatigue is thought to be caused by a neurological disorder or other regulatory dysfunction. [15] Individuals whose BMI is over 30kg/m2 [16] Individuals with drug and food allergies. [17] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which claim to improve eye-related functions or contain active ingredients that are expected to have an effect on the eyes in the past 3 months or will ingest those foods during the test period. [18] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [19] Individuals who may change their lifestyle during the examination period. [20] Individuals who engage in a night work. [21] Individuals who are or are possibly pregnant, or are lactating. [22] Individuals who participated in other clinical studies in the past 3 months. [23] Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Schirmer's test (1) (1): Screening , Observation Period I , Observation Period II .
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1] Visual Analogue Scale (1) [2] Tear film break-up time (2) *Safety [1] Blood pressure, pulsation (2) [2] Weight, body fat percentage, BMI (2) [3] Doctor's questions (2) [4] Subject's diary (3) *Other index [1] Baseline characteristics (4) [2] Height measurement (4) [3] Hematologic test (4) [4] Blood biochemical test (4) [5] Urine analysis (4) [6] General ophthalmologic examination (visual acuity, intraocular pressure measurement, fundus examination, slit-lamp microscopy, dominant eye judgement, refraction test) (4) (1): Observation Period I, Observation Period II. (2): Screening, Observation Period I, Observation Period II. (3): Everyday from the starting day of Test Period I to the last day of the study. (4): Screening.