To Evaluate the Efficacy of Lutemax 2020 on Vision and Cognitive Performance in Health Children.

A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Children

To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children

Study Overview

• Status: Completed
• Conditions: Cognitive
• Intervention / Treatment: Dietary supplement: Lutemax 2020 gummies; Other: Placebo

Detailed Description

Extensive exposure to digital devices like laptops, smart phones, etc.is a result of advanced technology in today's modern world. Especially, the children of 21st century are avid users of technology. The precipitous rise in the use of digital devices has raised concerns about potentially deleterious health effects due to increased screen time and associated exposure to short wavelength blue light. Adverse effects include damage to retina, physical health and cognitive performance. To adapt to this change, a diet-derived, blue-absorbing pigment, composed of the dietary carotenoids lutein (L) and zeaxanthin (Z), which are found in relatively high concentrations in leafy-green vegetables, and along with the Z isomer mesozeaxanthin (MZ), are deposited in rich concentrations in the macular retina. They play an important role in protecting the retina from cumulative damage that can result in visual and cognitive detriments and further progress to Age-related Macular Degeneration (AMD). To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children. Efficacy will be evaluated based on the effect of Lutemax 2020 on MPOD and other visual parameters, visual processing speed, contrast sensitivity along with cognitive performance parameters in comparison with the baseline readings. Serum parameters such as BDNF, L and Z concentrations will also be assessed and compared with the baseline levels.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560001
      • Sanjeevini Netralaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children (Male/female) of ≥5 and ≤12 years of age
2. Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height
3. Participants with screen time i.e., exposure to digital devices for minimum 4 hours per day
4. Participants who agree to maintain their usual dietary habits throughout the trial period.
5. Participants who agree to maintain their usual level of activity throughout the trial period
6. Participants demonstrates understanding of the study and willingness to participate as evidenced by participant's parents or legally authorized representative's by giving voluntary written informed consent.
7. Participants willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study

Exclusion Criteria:

1. Participants ˂ 5 or ˃ 12 years of age
2. Participants having hypersensitivity or history of allergy to the study product or any of its ingredients
3. Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
4. Participants having a current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
5. Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries
6. Participants consuming carotenoid supplements including lutein and zeaxanthin, anti-oxidant supplements, iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month prior to screening visit
7. Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
8. Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial
9. Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lutemax 2020 gummies; Administered once a day for the duration of 6 month.	Dietary supplement: Lutemax 2020 gummies; Lutein 10 mg & Zeaxanthin isomers 2 mg
Placebo Comparator: Placebo Gummies; Administered once a day for the duration of 6 month.	Other: Placebo; Placebo gummies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MPOD	Mean change in Macular Pigment Optical Density (MPOD) from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual processing speed	Mean change in visual processing speed from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)	6 months
Change in contrast sensitivity	Mean change in contrast sensitivity from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)	6 months

Collaborators and Investigators

• Sponsor: Bioagile Therapeutics Pvt. Ltd.
• Investigators: Study Director: Divya Chandradhara, Msc, divya@bioagiletherapeutics.com

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BIAG-CSP-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No