CognitiveNCT07355725
To Evaluate the Efficacy of Lutemax 2020 on Vision and Cognitive Performance in Health Children.
A study testing Lutemax 2020 gummies in people with Cognitive, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive
- What is being tested?
- Lutemax 2020 gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jul 2022to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cognitive
- Being tested
- Lutemax 2020 gummies, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutemax 2020 gummiesDietary supplement
Lutein 10 mg \& Zeaxanthin isomers 2 mg
PlaceboOther
Placebo gummies
| Study group | Role | What they receive |
|---|---|---|
| Lutemax 2020 gummies | Experimental | Administered once a day for the duration of 6 month. Receives: Dietary Supplement: Lutemax 2020 gummies |
| Placebo Gummies | Placebo comparator | Administered once a day for the duration of 6 month. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (2)
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)
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start21 Jul 2022
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divya Chandradhara, Msc, Study director, divya@bioagiletherapeutics.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355725
- Sponsor's protocol ID
- BIAG-CSP-052
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07355725
- Acronym / sponsor ID
- BIAG-CSP-052
- Conditions
- Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutemax 2020 gummies | Experimental | Dietary Supplement: Lutemax 2020 gummiesAdministered once a day for the duration of 6 month. |
| Placebo Gummies | Placebo comparator | Other: PlaceboAdministered once a day for the duration of 6 month. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutemax 2020 gummiesLutein 10 mg \& Zeaxanthin isomers 2 mg | Dietary supplement | Lutemax 2020 gummies |
| PlaceboPlacebo gummies | Other | Placebo Gummies |
Primary outcome
Change in MPOD
Time frame: 6 months
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)
2 secondary outcomes
Change in visual processing speed
Time frame: 6 months
Change in contrast sensitivity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Divya Chandradhara, Msc study director
divya@bioagiletherapeutics.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutemax 2020 gummies in people with Cognitive, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MPOD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.