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

Bioagile Therapeutics Pvt. Ltd.

Status

Completed

Conditions

Cognitive

Treatments

Other: Placebo

Dietary Supplement: Lutemax 2020 gummies

Study type

Interventional

Funder types

Industry

Identifiers

NCT07355725

BIAG-CSP-052

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

5 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children (Male/female) of ≥5 and ≤12 years of age
Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height
Participants with screen time i.e., exposure to digital devices for minimum 4 hours per day
Participants who agree to maintain their usual dietary habits throughout the trial period.
Participants who agree to maintain their usual level of activity throughout the trial period
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.
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

Participants ˂ 5 or ˃ 12 years of age
Participants having hypersensitivity or history of allergy to the study product or any of its ingredients
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
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
Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries
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
Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial
Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol