None
Conditions
Interventions
Lutein group:Lutein gluconate zinc vitamin apsules
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1)The inclusion criteria of healthy subjects were 18 to 50 years old (including the cut-off value), body mass index (BMI) = weight (kg)/height (m2), body mass index (BMI) in the range of 20 to 27 (including the cut-off value), and >=50 kg for men and >=45 kg for women; 2)Participants avoided lutein and zeaxanthin -- vegetables and fruits rich in yellow and green colors -- for 2 weeks before and during the trial, Such as mango, orange, asparagus, broccoli, winter melon, pumpkin, coriander, kale, orange pepper, parsley, papaya, peas, pistachio, romaine lettuce, scallion, zucchini, kale, kale, spinach, carrots, corn, tomatoes, nectarines, peaches, etc. If needed, no more than 2 servings per day should be consumed; 3)Participants avoided eating eggs for 2 weeks before and during the study; 4)The subjects did not smoke or drink heavily; 5)Disease markers for HIV 1 and 2, hepatitis B, and hepatitis C viruses were absent; 6)There were no significant illnesses or clinically significant abnormal laboratory values on laboratory evaluation, history, physical examination, and systemic examination during screening; 7)Before the trial, they fully understood the content, process and possible adverse reactions of the trial, and voluntarily signed the informed consent; 8)Be able to complete the study in accordance with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1)The state of pregnancy, lactation, or preparation for pregnancy; 2)Patients who are allergic to lutein and zeaxanthin; 3)History or evidence of chronic disease, such as diabetes, hypertension, liver disease, kidney disease, lung disease or infectious disease, cardiovascular disease, pancreatic disease, infectious disease, skin disease, arthritis, cancer; 4)Symptoms include fever, gastrointestinal bleeding, unexpected weight loss, anemia, dysphagia, or an abdominal mass; 5)history of milk allergy, gluten allergy, or other known food intolerance and/or any food allergy; 6)History of major systemic illness, epilepsy, psychiatric disorder, neurological disorder, depression, psychiatric disorder, or allergic rash; 7)history of difficult blood donation or difficult venous patency; 8)Any history of drug addiction or dependence; 9)Have participated in any other clinical study within the past 90 days; 10)Use of other prescription or over-the-counter medications in the 30 days before screening; 11)Vitamin or multivitamin supplements that provide carotenoids (e.g., supplements that include lutein) zeaxanthin, ß-carotene, lycopene, or ß-cryptoxanthin) are currently being used; 12)history of dehydration due to diarrhea, vomiting, or other causes within 24 hours before the start of the study; 13)For whatever reason, such as fasting for religious reasons, an unusual or abnormal diet was present within 48 hours before the start of the study; 14)Drugs known to significantly induce or inhibit drug-metabolizing enzymes were received within 14 days of study initiation; 15)Foods and beverages containing xanthine (chocolate, tea, coffee, or cola drinks) were consumed within 48 hours before the start of the study; 16)Grapefruit and grapefruit like citrus fruit (mosambi/sweet lime) or juice were consumed within 7 days before the study. 17)Urine was positive for benzodiazepines, opioids, amphetamines, cannabinoids, cocaine, and barbiturates; 18)Macular carotenoid supplements, omega-3 fatty acids, alpha-lipoic acid, or fatty acid supplements were used within 14 days of the start of the study; 19)History of current use of lutein and/or zeaxanthin supplements (i.e. within 60 days of the screening visit);; 20)Alcohol breath analysis was positive at enrollment during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal climination halflife;Terminal elimination rate constant;Mean residence time;Area under the curve of 0-12h;Peak time;Peak concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic and ocular anaphylaxis; | — |
Countries
China
Contacts
Public ContactWu Junyan
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed