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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Vision; Eye Health
• Intervention / Treatment: Dietary supplement: VisionPure Dietary Supplement; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lutz, Florida, United States, 33549
      • True Eye Experts - Lutz
    • Tampa, Florida, United States, 33607
      • Applied Science and Performance Institute
    • Tampa, Florida, United States, 33647
      • True Eye Experts - New Tampa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VisionPure Dietary Supplement; 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; 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.
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)	Subjective/Self-Reported Eye Health Questionnaire.	Day 0, Day 60

Collaborators and Investigators

• Sponsor: Applied Science & Performance Institute
• Collaborators: True Eye Experts - New Tampa
• Investigators: Principal Investigator: Jacob Wilson, Ph.D., The Applied Science and Performance Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin D; Fish Oil; Cognitive Function; Antioxidant; Eye Health; Vision Health
• Other Study ID Numbers: 1221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No