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

NCT ID: NCT05533658

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-02-03

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.

Conditions

Eye Health; Vision; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

VisionPure Dietary Supplement

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

True Eye Experts - New Tampa

UNKNOWN

Sponsor Role: collaborator

Applied Science & Performance Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Wilson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Applied Science and Performance Institute

Locations

True Eye Experts - Lutz

Lutz, Florida, United States

Applied Science and Performance Institute

Tampa, Florida, United States

True Eye Experts - New Tampa

Tampa, Florida, United States

Countries

United States

Other Identifiers

1221

Identifier Type: -

Identifier Source: org_study_id