The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function

Study Overview
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Brief Summary
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VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. Prior to and following the 60 day supplementation period, participants will undergo a series of optometry and cognitive examinations to quantify eye health and cognitive function outcomes.

Detailed Description
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The study design is a randomized, double-blind, placebo-controlled, parallel design, pilot trial. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. All study-related procedures will be carried out at 2 locations, The Applied Science and Performance Institute, as well as at True Eye Experts. Both locations are in Tampa, FL. All screening for the study and the signing of all IRB documents will be held at the Applied Science and Performance Institute. Optometry eye examination at Day 0 and Day 60 will be conducted under the supervision of a board-certified O.D. at the True Eye Experts location. Computer-based cognitive assessments using a program called CNS Vital Signs will be carried out at Day 0 and Day 60 at the Applied Science and Performance Institute. The following exams will be carried out: Verbal Memory, Visual Memory, Composite Memory, and Cognitive Attention.

Official Title
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The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.

Conditions
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Eye Health, Vision, Cognitive Function

Intervention / Treatment
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* Dietary Supplement: VisionPure Dietary Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 18-40 years English literate Willing to sign informed consent form Exclusion Criteria: Current cataracts or prior cataract extraction Glaucoma Uveitis Macular hole or traction Retinitis pigmentosa Significant epiretinal membrane Dry eye syndrome of any form LASIK procedure Diagnosed concussion within the last 6 months Optic neuropathy Neurological disease Metabolic disease Cardiovascular disease Renal disease History of previous ocular surgery, trauma, intraocular injections or photocoagulation Vitamin D3, omega fatty acids, or fish oil supplementation with the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VisionPure Dietary Supplement<br>One dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 976mg fish oil (120mg eicosapentaenoic acid, 610 mg docosahexaenoic acid), 20mg lutein, 4mg zeaxanthin isomers, 25mcg vitamin D3. | Dietary Supplement: VisionPure Dietary Supplement<br>* Subjects will consume two softgels capsules of the Treatment (VisionPure) once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.<br>|
| Placebo Comparator: Placebo<br>One dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 727mg organic sunflower oil, 15mg organic lemon essential oil, 1.5mg vitamin E T-70, 0.7mg natural fish flavor. | Dietary Supplement: Placebo<br>* Subjects will orally consume two softgel capsules of Placebo once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ganglion Cell Complex Thickness | Diagnostic Procedure: Retinal Optical Coherence Tomography | Day 0, Day 60 | 
| Change in Central Retinal Thickness | Diagnostic Procedure: Retinal Optical Coherence Tomography | Day 0, Day 60 | 
| Change in Intraocular Pressure | Diagnostic Procedure: Retinal Optical Coherence Tomography | Day 0, Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Acuity | Determines the clarity of your distance vision according to the Snellen Chart. | Day 0, Day 60 | 
| Change in Color Vision | Determines the normality of or defectiveness of color vision. Reference Range: 1 to 11 according to Ishihara Plates (>10 is normal, 7 or <7 is deficient). | Day 0, Day 60 | 
| Change in Verbal Memory | How well can an individual recognize, remember, and recall words. | Day 0, Day 60 | 
| Change in Visual Memory | How well can in individual recognize, remember, and recall a combination of words and images. | Day 0, Day 60 | 
| Change in Composite Memory | How well an individual can recognize, remember, and recall a combination of words and images. | Day 0, Day 60 | 
| Change in Cognitive Attention | The ability to handle multiple tasks at once and shift attention. | Day 0, Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish Oil, Vitamin D, Antioxidant, Eye Health, Cognitive Function, Vision Health