A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Trial Study to Evaluate the Safety and Efficacy of Lutemax 2020 on Cognitive and Vision Performance in Healthy Adults

This study is a Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled clinical trial designed to evaluate the safety and efficacy of Lutemax 2020 on cognitive and vision performance in healthy adults. A total of 152 eligible healthy subjects (both male and female), aged 45 to 70 years (both inclusive), will be enrolled.

The study will be conducted over a 191-day period and will consist of five key clinical visits:

Visit 1: Screening/Baseline (Day -7 to Day -1)

Visit 2: Randomization (Day 0)

Visit 3: First Follow-Up (Day 42 ± 3 days)

Visit 4: Second Follow-Up (Day 90 ± 3 days)

Visit 5: End of Study (Day 180 + 3 days)

At the screening stage, potential subjects will be informed in detail about the study procedures, associated risks and discomforts, and the investigational products (IP). Written informed consent will be obtained from subjects willing to participate. Upon signing the consent form, subjects will be enrolled and screened for eligibility, including a comprehensive review of the inclusion and exclusion criteria. Those who meet all inclusion criteria and none of the exclusion criteria will proceed to the baseline assessment. The screening period is defined as Day -7 to Day -1. During each visit, participants will report to the investigational site for scheduled assessments and safety monitoring. If deemed eligible during Visit 2 (Randomization Visit), subjects will be randomly assigned in a 1:1 ratio (double-blind) to one of two arms and a separate randomization number will be provided to the subject:

Lutemax 2020 arm

Placebo arm

Randomization will be conducted using a R-program, version 4.3.3. Blinding will be maintained through coded labeling and controlled distribution of study interventions. Treatment codes will be securely stored and only accessible to designated unblinded personnel. To control for dietary intake of Lutein and Zeaxanthin, data on Lutein and Zeaxanthin will be captured in three-day food records and will be reviewed by the study team. Details of prior and concomitant medications will be obtained and documented.

The study IP will be dispensed by an independent dispenser or designated site personnel who will not participate in any other study-related activities related to safety or efficacy assessments, thereby ensuring blinding integrity and reducing bias. Subjects will be instructed to consume one capsule every morning after breakfast, at the same time each day, for a duration of 180 consecutive days (+3 days allowance). Throughout the study, safety assessments will include: Monitoring of adverse events (AEs), Physical examinations, Vital sign measurements, Hematology and clinical chemistry laboratory evaluations Clinical assessments will address all measures required to meet both the primary and secondary objectives of the study, including cognitive, visual, and biochemical parameters. To assess serum lutein and zeaxanthin (L/Z) levels, approximately total 6 mL of venous blood will be collected from each subject throughout study period at defined visits as per schedule of activities chart. An additional total volume of 14.5 mL of venous blood will be drawn per subject for other laboratory assessments, including the evaluation of serum BDNF levels through the study period at defined visits as per schedule of activities chart. The Macular Pigment Density (MPD) will be assessed using the MP-eye™ device (Azul Optics) at Visits 2, 3, 4, and 5. At each visit, MPD measurement will be performed twice. First, immediately upon the subject’s arrival, and again following the completion of the CNS Vital Signs cognitive assessments. Both the readings should be recorded in case record form. The Visual Processing Speed, measured by the Critical Flicker Fusion (CFF) test, will also be conducted at Visits 2, 3, 4, and 5. During each visit, the test will be performed three times consecutively to ensure reliability and accuracy. The average value from the three readings will be considered for data analysis. To monitor adherence, a Subject Diary will be provided to all participants. They will be instructed to record:

Daily study IP administration

Any side effects or symptoms

Details of any concomitant medications

Subjects must update the diary after each dose, noting any missed or additional administrations. The diary will be reviewed regularly to evaluate compliance with the treatment protocol. In cases where it is necessary to see a subject outside of the scheduled visits, an unscheduled visit procedure will be followed. If a subject must be discontinued from the study at any time, the investigator will use clinical judgment to ensure standard care is provided, and the End of Study procedures will be performed at that point. Statistical analyses will involve comparative evaluation of efficacy outcomes between the test product (Lutemax 2020) and placebo arms.