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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533658
• Other study ID #: 1221
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: October 2022
• Source: Applied Science & Performance Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 3, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Eye Health
• Vision

Intervention

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
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.

Locations

Country	Name	City	State
United States	True Eye Experts - Lutz	Lutz	Florida
United States	Applied Science and Performance Institute	Tampa	Florida
United States	True Eye Experts - New Tampa	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Applied Science & Performance Institute	True Eye Experts - New Tampa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)	Subjective/Self-Reported Eye Health Questionnaire.	Day 0, Day 60
Primary	Change in Ganglion Cell Complex Thickness	Diagnostic Procedure: Retinal Optical Coherence Tomography	Day 0, Day 60
Primary	Change in Central Retinal Thickness	Diagnostic Procedure: Retinal Optical Coherence Tomography	Day 0, Day 60
Primary	Change in Intraocular Pressure	Diagnostic Procedure: Retinal Optical Coherence Tomography	Day 0, Day 60
Secondary	Change in Visual Acuity	Determines the clarity of your distance vision according to the Snellen Chart.	Day 0, Day 60
Secondary	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
Secondary	Change in Verbal Memory	How well can an individual recognize, remember, and recall words.	Day 0, Day 60
Secondary	Change in Visual Memory	How well can in individual recognize, remember, and recall a combination of words and images.	Day 0, Day 60
Secondary	Change in Composite Memory	How well an individual can recognize, remember, and recall a combination of words and images.	Day 0, Day 60
Secondary	Change in Cognitive Attention	The ability to handle multiple tasks at once and shift attention.	Day 0, Day 60