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

Sponsor

Applied Science & Performance Institute (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05533658

Collaborator

True Eye Experts - New Tampa (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

5.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Health Vision Cognitive Function	Dietary Supplement: VisionPure Dietary Supplement Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Ganglion Cell Complex Thickness [Day 0, Day 60]
Diagnostic Procedure: Retinal Optical Coherence Tomography
Change in Central Retinal Thickness [Day 0, Day 60]
Diagnostic Procedure: Retinal Optical Coherence Tomography
Change in Intraocular Pressure [Day 0, Day 60]
Diagnostic Procedure: Retinal Optical Coherence Tomography

Secondary Outcome Measures

Change in Visual Acuity [Day 0, Day 60]
Determines the clarity of your distance vision according to the Snellen Chart.
Change in Color Vision [Day 0, Day 60]
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).
Change in Verbal Memory [Day 0, Day 60]
How well can an individual recognize, remember, and recall words.
Change in Visual Memory [Day 0, Day 60]
How well can in individual recognize, remember, and recall a combination of words and images.
Change in Composite Memory [Day 0, Day 60]
How well an individual can recognize, remember, and recall a combination of words and images.
Change in Cognitive Attention [Day 0, Day 60]
The ability to handle multiple tasks at once and shift attention.

Other Outcome Measures

Changes in National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) [Day 0, Day 60]
Subjective/Self-Reported Eye Health Questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	True Eye Experts - Lutz	Lutz	Florida	United States	33549
2	Applied Science and Performance Institute	Tampa	Florida	United States	33607
3	True Eye Experts - New Tampa	Tampa	Florida	United States	33647