clinical trial to improve eye health in elderly volunteers

INTERVENTION: Intervention1: XanMa X2004 (Lutein/zeaxanthin 33mg in the ratio of 5:1): Dose:300mg (Each capsule contains 33 mg of Lutein/ Zeaxanthin (5:1) Dosage form: soft gel capsule Route of administration: Oral Frequency: One capsule orally 30 minutes after breakfast Duration: 60 days Control Intervention1: Placebo: Dose:300mg, Dosage form: soft gel capsule Route of administration: Oral Frequency: One capsule orally 30 minutes after breakfast Duration: 60 days CONDITION: Health Condition 1: H36‐ Retinal disorders in diseases classified elsewhere PRIMARY OUTCOME: Changes in MPOD levelsTimepoint: Day 0, Day 30 and Day 60 SECONDARY OUTCOME: Safety Assessments (hematology, serum chemistry and urine analysis)Timepoint: Day 0 and Day 60 INCLUSION CRITERIA: 1. Volunteers of any sex, aged 45 to 65 years. 2. Volunteers with a body mass inde X(BMI) between 20 and 33 kg/m². 3. Volunteers with macular pigment optical density (MPOD) levels between 0.1 and 0.4. 4. Volunteers with no clinically significant ocular pathological conditions (minor and clinically insignificant accommodation issues of the eyes may be included). 5. Willing and able to adhere to the dietary regimen outlined in the study protocol. 6. Willing to attend regular follow‐up visits as specified in the study protocol. 7. Capable of providing written informed consent.