None listed
Conditions
Interventions
Intervention1: XanMax 2004-TZ,: Dose: 300 mg(Each capsule contains 20 mg of lutein and 4 mg of trans-zeaxanthin derived from XanMax 2004 oil, with a total capsule weight of 300 mg.)Route of administ
Sponsors
Katra Phytochem (India) Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Volunteers of any sex, aged 40 to 70 years. 2.Volunteers with a body mass index (BMI) between 20 and 29.9 kg/m . 3.Volunteers with macular pigment optical density (MPOD) levels between 0.2 and 0.4. 4.Volunteers with no clinically significant ocular pathological conditions (minor and clinically insignificant accommodation issues of the eyes may be included). 5.Willing and able to adhere to the dietary regimen outlined in the study protocol. 6.Willing to attend regular follow-up visits as specified in the study protocol. 7.Capable of providing written informed consent. 8.Subjects willing to refrain from taking any medications or supplements for improving cognitive performance, memory and mood, and reducing stress/anxiety during the study 9.Subjects willing to refrain from consuming alcohol 24 hours prior to the test days 10.Subjects must report a minimum average daily screen time of more than equal to 4 hours, including usage of computers, tablets, smartphones, or televisions. 11.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hours prior to test days 12.Subjects willing to refrain from vigorous physical activity 12 hours prior to test days.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to herbal extracts, dietary supplements, or study-related components. 2.Presence of clinically significant ocular pathologies, including but not limited to glaucoma, mature cataracts, or pan-retinal degenerations. 3.Subjects with diagnosis of cognitive decline 4.History diagnosis of systemic diseases such as hypercholesterolemia, renal disorders, hepatic disorders, diabetes mellitus, or other debilitating conditions. 5.Current or recent treatment in the last three months with herbal or allopathic ocular medications. 6.Participation in any other clinical trial or receipt of an investigational drug within the last three months. 7.Any condition that, in the investigators judgment, would preclude safe participation in the study or compromise study results. 8.Pregnant or lactating women, women planning to conceive during the study period, or women less than six months postpartum. 9.Prior use of lutein, zeaxanthin, or other antioxidant replacement therapies within the six months preceding the study. 10.Subjects who are on memory enhancing medications, anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: To evaluate the effect of XanMax 2002, XanMax 2004 TZ, and XanMax 2022 compared to placebo on: 1.Change in mean Macular Pigment Optical Density MPOD from baseline Visit 1 Day 0 to Visit 2 Day 45 and Visit 3 Day 90. 2.Change in overall sleep quality using the Pittsburgh Sleep Quality Index PSQI from baseline Visit 1 Day 0 to Visit 2 Day 45 and Visit 3 Day 90.Timepoint: Day 0 Day 45 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: To evaluate the safety and additional efficacy of XanMax 2002, XanMax 2004 TZ, and XanMax 2022 compared to placebo from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90), as assessed by the following: 1. Change in photo stress recovery time from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90) among the four study arms. 2. Change in glare disability scores from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90) among the four study arms. 3. Change in central foveal thickness, as measured by Optical Coherence Tomography (OCT), from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90) among the four study arms 4. Change in eye strain and eye fatigue using Visual Analogue Scales (VAS) from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90).Timepoint: Day 0, Day 45 and Day 90.;5. Change in outcomes associated with prolonged blue light exposure from digital devices, including eye strain and fatigue, headache frequency, and glare tolerance, from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90). 6. Change in stress related parameters, including feelings of occasional stress (using validated scales) from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90)and serum cortisol levels, from baseline (Visit 1, Day 0) to Visit 3 (Day 90).Timepoint: Day 0 Day 45 and Day 90;7. Incidence of adverse events (AEs) and serious adverse events (SAEs) from baseline (Visit 1, Day 0) through Visit 3 (Day 90). 8. Changes in vital signs, laboratory parameters, and physical examination findings from baseline (Visit 1, Day 0) to Visit 2 (Day 45) and Visit 3 (Day 90). Timepoint: Day 0 Day 45 and Day 90 | — |
Countries
India
Contacts
Public ContactMs Priya M K
Katra Phytochem (India) Pvt Ltd
Outcome results
None listed