None listed
Conditions
Interventions
Intervention1: Lutemax 2020™: Lutemax 2020™ is a patented extract containing all three nutritionally relevant macular
carotenoids—lutein, RR-zeaxanthin, and RS (meso)-zeaxanthin— in the same 5:1 rati
Sponsors
OmniActive Health Technologies Ltd
Eligibility
Inclusion criteria
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 of 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in visual processing speed from Baseline (Day-7 to Day-1) to Visit 5, End of Study Visit (Day 180 plus 3 days) 2.Mean change in contrast sensitivity from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 plus 3 days) Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDivya C
Bioagile Therapeutics Limited
Outcome results
None listed