Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05533658
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function
Sponsor:
Applied Science & Performance Institute
Organization:
Study Overview
Official Title:
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: