Effects of consumption of the test food on eye functions in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000039370
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Kanai T, Takahashi Y, Takara T. Effects of the consumption of "Pintokuru-cassis" foods containing cassis extract on eye functions in healthy Japanese subjects: A randomized, placebo-controlled, double-blind, parallel-group comparison study. New Food Indust. 2021; 63(1): 3-21
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hemorrhagic disorder, intestinal disorder, or any other chronic diseases 4. Subjects who were diagnosed as presbyopia or are aware of presbyopia 5. Subjects who have eye diseases, entropion or trichiasis 6. Subjects who use eye drops for treatment of eye diseases 7. Subjects who have ametropia and do not be treated orthoptics properly 8. Subjects who were treated with LASIK 9. Subjects who are strong astigmatism 10. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 12. Currently taking medicines (include herbal medicines) and supplements 13. Subjects who regularly take or may take antihypertensives, antiplatelet drug or anticoagulants 14. Subjects who may use anesthetics during the test period, such as surgery 15. Subjects who are allergic to medicines and/or the test food related products 16. Subjects who are pregnant, breast-feeding, and planning to become pregnant 17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18 Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change of percentage of pupillary response (average of both eyes) before and after VDT load between at examination before the start of test-food consumption (screening) and after four-week test-food consumption (4w).
- Secondary Outcome Measures
Name Time Method