None listed
Conditions
Interventions
Intervention1: Lutein and Zeaxanthin 20 mg: Dose :500mg,Doasge form:Capusle,
Duration 90 days, 1 capsule per day in the morning with breakfast.
Intervention2: Lutein and Zeaxanthin 40 mg: Dose :500mg,
Sponsors
M/s. Nutrione
Botanic Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers of either sex between 40 to 85 years of age 2. Volunteers with a BMI 25 to 33 Kg per m2 3. Amenorrhea for more than 2 years 4. Volunteers with MPOD level between 0.2 to 0.4 5. Volunteers with; Wet AMD: Exudative AMD in at least one eye; Dry AMD: From early to intermediate stages 6. Able to abide the dietary regime mentioned in the protocol 7. Willing to come for regular follow up visits 8. Able to give written informed consent willingness to take part in study and able to attend all scheduled visits
Exclusion criteria
Exclusion criteria: 1. Hyperlipidemia greater than 6.2 mmol per L 2. People with other ophthalmic diseases besides AMD,those undergoing retinal surgery or retinal laser treatment 3. People with macular atrophy 4. People with signs of exudative changes including subretinal fluid, pigment epithelial detachment or hemorrhage in the retina 5. People with Myopia greater than 6 diopters 6. People with cataracts or corneal opacities 7. People with uncontrolled hypertension SBP greater than 140mmHg or DBP greater than 90mmHg 8.People with uncontrolled diabetes HbA1C greater than 7.0 percent 9. People with Rheumatoid arthritis. 10. Pregnant women or those preparing for pregnancy 11. Breastfeeding women 12. Drug addicts 13. People taking medications or controlled diet for Hyperlipidemia 14. Those undergoing hormone replacement therapy 15. People who regularly take supplements or health functional foods 16. People who regularly use eye drops 17. Alcohol addicts- Men greater than or equal to 40 g per day and Women greater than or equal to 20g per day, based on WHO daily alcohol intake guidelines 18. Heavy smokers greater than or equal to 20 cigarettes per day 19. Contact lens wearers: those who wear lenses for more than 3 days a week 20. People with allergies or adverse reactions to the test substances 21. People who have taken health functional foods related to the corresponding functionality within 3 months prior to the start of the trial 22. People who have participated in other clinical trials within the last 3 months 23. Those deemed unsuitable for the experiment by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: 1. Changes in MPOD levels (Screening visit,Day 0, Day 45, Day 90) 2. Changes in contrast enhancement measurements 3. Changes in Lutein and Zeaxanthin plasma concentrationsTimepoint: Day 0, Day 45, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome 1. To assess the safety of Lutein Zeaxanthin 164 through Safety assessments like, hematology, and biochemistry (LFT and RFT) (Screening visit ,Day 90) 2. To measure improvement in extending visual Field test using Humphrey visual field analyzer 3. Changes in glare disabilityTimepoint: Day 0, Day 45, Day 90. | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed