A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000033854
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Not provided
1)A person who is currently receiving any drug treatment or ambulatory treatment. 2)A person who is currently exercising or taking diet under the supervision of a physician. 3)Patients with a history of, present disease, or complication of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 4)Patients with chronic diseases (arrhythmias, hepatic disorders, renal disorders, cerebrovascular disorders, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases) who are being treated or have a history 5)Patients who have undergone gastrointestinal surgery (appendicitis is acceptable) 6)Patients with eye diseases other than refractive error (hyperopia, myopia, astigmatism) 7)Persons with a history of drug or food allergy 8)People who wish to do so during pregnancy, lactation, or the duration of the study 9)Persons who have received blood donations or immunizations within the last 3 months or who plan to receive them during the study period. 10)Persons who routinely consume health foods, supplements, and pharmaceuticals that may affect ocular function. 11)Persons with psychiatric disorders (depression, etc.) or sleep disorders who are attending hospital or who have a history of psychiatric illness in the past 12)Alcoholics, addicts, or abusers with or without a history of treatment 13)Persons who work on a shift basis, such as those who work at night 14)Persons with extremely irregular lifestyle habits such as diet and sleep 15)Current smokers 16)Currently participating in other clinical trials or participating in other clinical trials within the last 3 months of the date of informed consent 17)Persons with difficulties in observing records on various questionnaires 18)Other persons who are judged by the investigator to be inappropriate for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Macular pigment optical density
- Secondary Outcome Measures
Name Time Method Serum lutein concentration, contrast sensitivity