None listed
Conditions
Interventions
Intervention1: Lutemax 2020 20% OS in a softgel capsule Strength: 100 mg containing Lutein 20 mg & Zeaxanthin isomers 4 mg
Control Intervention1: Placebo: Sunflower oil in a softgel capsule
Sponsors
OmniActive Health Technologies, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female adults, aged 45 to 70 years 2. Subjects with BMI between 20.00 to 29.99 kg/m2 (both limits inclusive) 3. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period 4. Subjects who agree to maintain their usual level of activity throughout the trial period 5. Subjects willing to refrain from taking any medications or supplements for improving cognitive performance, memory and mood, and reducing stress/anxiety during the study 6. Subjects willing to refrain from consuming alcohol 24 hours prior to the test days 7. Subjects must report a minimum average daily screen time of more than equal to 4 hours, including usage of computers, tablets, smartphones, or televisions. 8. Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hours prior to test days 9. Subjects willing to refrain from vigorous physical activity 12 hours prior to test days 10. Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year. 11. Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject) 12. Subjects willing to provide written consent. 13. Subjects shall be 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
Exclusion criteria: 1. Having hypersensitivity or history of allergy to the study product 2. Subjects with diagnosis of cognitive decline 3. Subjects 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, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator 4. Subjects with a malignant disease or any concomitant end- state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 5. Subjects with a psychiatric diagnosis including anxiety or depression. 6. Subjects with sleep disturbances and/or are taking sleep aid medications 7. Subjects with uncontrolled hypertension (systolic blood pressure more than 160 mm Hg or diastolic blood pressure more than 100 mm Hg) at screening. 8. Subjects who are on memory enhancing medications, anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. 9. Recent history (3 months) of serious infections, injuries and/ or surgeries 10. Subjects with a history of drug and /or alcohol abuse at the time of enrolment 11. Subjects with positive Urine Pregnancy Test at Screening /Randomization Visit. 12. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Lutemax 2020 compared to placebo on memory related measures like composite memory, verbal memory, visual memory, working memory assessed by CNS Vital Signs from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Lutemax 2020 compared to placebo from baseline to 6 monthsTimepoint: [Baseline, Visit 2, Visit 3, Visit 4, Visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on cognitive performance measures like processing speed, simple attention, complex attention, psychomotor speed, reaction time, executive function, cognitive flexibility assessed, sustained attention by CNS Vital Signs from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on visual processing speed assessed by critical flicker fusion from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on macular pigment density (MPD) assessed by MP eye (Azul Optics) from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on eye strain and eye fatigue using Visual Analogue Scales from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on overall sleep quality using Pittsburgh Sleep Quality Index from randomization to 6 months.Timepoint: From visit 2- randomization visit to Visit 5;To evaluate the concentration of lutein and zeaxanthin in serum from baseline to 6 months.Timepoint: Baseline to visit 5;To evaluate the effect of Lutemax 2020 compared to placebo on serum BDNF levels from baseline to 6 months.Timepoint: Baseline to visit 5 | — |
Countries
India
Contacts
Public ContactAbhijeet Morde
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed