NCT05533658

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Applied Science & Performance Institute · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-30
• Completion: 2023-02-03
• First posted: 2022-09-09
• Last updated: 2023-05-26

Locations

3 sites across 1 country: United States