Healthy subjects
Conditions
Interventions
16-week intake of the containing lutein food of 2 capsules a day
16-week intake of the placebo food of 2 capsules a day
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese men and women aged 20 to 69 years at the time of informed consent 2)Persons with a BMI 25 kg of less than or equal to m2 3)Patients who have not undergone LASIK surgery (myopia correction surgery) 4)Patients with 0.7 or more corrected visual acuity in both eyes 5)Persons who can be contacted by personal computer or smartphone 6)Patients who can discontinue ophthalmic solutions during the study period. 7)A person who has received sufficient explanation on the purpose and content of the research, who has the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who has given written consent to participate in the research.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular pigment optical density | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum lutein concentration, contrast sensitivity | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed