A confirmatory study on the effect of continuous intake of test foods on eye functions and QOL. -A placebo-controlled, randomized, double-blind clinical trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000047328
- Lead Sponsor
- IMEQRD Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1.Currently undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed are acceptable. 2.Currently undergoing treatment for eye diseases. 3.Receiving nutritional and exercise therapy by medical doctors. 4.Have been received any eye surgery within one year before the day of the screening visit, or planning to receive any eye surgery during the study. 5.Used any eye drops, including OTC drugs within 2 weeks before the day of the screening visit. 6.Have any severe disease or any severe symptoms, or history of severe diseases, or will be unavoidably using any eye drop, including OTC drugs during the study. 7.Have pollinosis or allergic conjunctivitis. 8.Have been taking yogurts or lactic fermenting beverages. However, can discontinue taking these foods during the study is acceptable to join the study. 9.Have been taking foods with any functional claims containing DHA, EPA, or astaxanthin more than once a week. 10.Have been taking foods with functional claims for eye health (such as blueberry, purple sweet potato) more than once a week. 11.Have been taking fish or fish eggs more than four times a week. 12.Have regularly been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. 13.Have allergies to drugs or foods. 14.Planning extremely change lifestyle (such as diet, sleep, or exercise) during the study. 15.Currently pregnant or breastfeeding, or planning to pregnant during the study. 16.Shift workers. 17.Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the study. 18.Unsuitable for the study, that judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Japanese version of Ocular Surface Disease Index (J-OSDI) Dry Eye related Quality of life Score (DEQS) Tear film break-up time (BUT) measurement Schirmer test
- Secondary Outcome Measures
Name Time Method Accommodation of eye Subjective questionnaires Computer Vision Syndrome Score Total cholesterol HDL-C LDL-C Blood cortisol