NCT Number: NCT05533658
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
True Eye Experts - Lutz, Lutz, Florida, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
Time frame: Day 0, Day 60
Determines the clarity of your distance vision according to the Snellen Chart.
Time frame: Day 0, Day 60
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).
Time frame: Day 0, Day 60
How well can an individual recognize, remember, and recall words.
Time frame: Day 0, Day 60
How well can in individual recognize, remember, and recall a combination of words and images.
Time frame: Day 0, Day 60
How well an individual can recognize, remember, and recall a combination of words and images.
Time frame: Day 0, Day 60
The ability to handle multiple tasks at once and shift attention.
Time frame: Day 0, Day 60
Subjective/Self-Reported Eye Health Questionnaire.
Applied Science & Performance Institute
Industry
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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