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

Applied Science & Performance Institute

Status: Completed

Conditions: Cognitive Function; Eye Health; Vision

Treatments: Dietary Supplement: Placebo; Dietary Supplement: VisionPure Dietary Supplement

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05533658

1221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

VisionPure Dietary Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: VisionPure Dietary Supplement

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo