Clinical trial NCT05533658: The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function
Official title: The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Health
Vision
Cognitive Function
Keywords: Fish Oil
Vitamin D
Antioxidant
Eye Health
Cognitive Function
Vision Health
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
Collaborators: name: True Eye Experts - New Tampa
First posted: 2022-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Ganglion Cell Complex Thickness
timeFrame: Day 0, Day 60
measure: Change in Central Retinal Thickness
timeFrame: Day 0, Day 60
measure: Change in Intraocular Pressure
timeFrame: Day 0, Day 60
Secondary outcomes:
measure: Change in Visual Acuity
timeFrame: Day 0, Day 60
measure: Change in Color Vision
timeFrame: Day 0, Day 60
measure: Change in Verbal Memory
timeFrame: Day 0, Day 60
measure: Change in Visual Memory
timeFrame: Day 0, Day 60
measure: Change in Composite Memory
timeFrame: Day 0, Day 60
measure: Change in Cognitive Attention
timeFrame: Day 0, Day 60
Other outcomes:
measure: Changes in National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
timeFrame: Day 0, Day 60
Locations:
city: Lutz
country: United States
facility: True Eye Experts - Lutz
state: Florida
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
city: Tampa
country: United States
facility: True Eye Experts - New Tampa
state: Florida
Study officials:
affiliation: The Applied Science and Performance Institute
name: Jacob Wilson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: