NCT05533658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

May 26, 2023

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

September 6, 2022

Last Update Submit

May 25, 2023

Conditions

Eye HealthVisionCognitive Function

Keywords

Fish OilVitamin DAntioxidantEye HealthCognitive FunctionVision Health

Outcome Measures

Primary Outcomes (3)

  • Change in Ganglion Cell Complex Thickness

    Diagnostic Procedure: Retinal Optical Coherence Tomography

    Day 0, Day 60

  • Change in Central Retinal Thickness

    Diagnostic Procedure: Retinal Optical Coherence Tomography

    Day 0, Day 60

  • Change in Intraocular Pressure

    Diagnostic Procedure: Retinal Optical Coherence Tomography

    Day 0, Day 60

Secondary Outcomes (6)

  • Change in Visual Acuity

    Day 0, Day 60

  • Change in Color Vision

    Day 0, Day 60

  • Change in Verbal Memory

    Day 0, Day 60

  • Change in Visual Memory

    Day 0, Day 60

  • Change in Composite Memory

    Day 0, Day 60

  • +1 more secondary outcomes

Other Outcomes (1)

  • Changes in National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)

    Day 0, Day 60

Study Arms (2)

VisionPure Dietary Supplement

EXPERIMENTAL

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.

Dietary Supplement: VisionPure Dietary Supplement

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

VisionPure Dietary SupplementDIETARY_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.

VisionPure Dietary Supplement
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Age 18-40 years
  • English literate
  • Willing to sign informed consent form

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

True Eye Experts - Lutz

Lutz, Florida, 33549, United States

Location

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

True Eye Experts - New Tampa

Tampa, Florida, 33647, United States

Location

Study Officials

  • Jacob Wilson, Ph.D.

    The Applied Science and Performance Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 9, 2022

Study Start

August 1, 2022

Primary Completion

January 30, 2023

Study Completion

February 3, 2023

Last Updated

May 26, 2023

Record last verified: 2022-10

Locations

US(3)