MedTrace Logo

Carotenoids for Collision Athletes

NCT06270680 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-03-11

No results posted yet for this study

Summary

This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.

Conditions

  • Head Injury
  • Carotenoids

Interventions

DRUG

Vision Edge Pro

Each dose will consist of one supplement capsule containing 10 mg lutein, 2 mg zeaxanthin, 10 mg mesozeaxanthin, 50mg EPA, 250mg DHA. Capsules are to be taken orally, once daily with a meal. Duration of supplementation will last approximately 2 - 5 months, depending on the length of the athletic seasons for the sports recruited.

OTHER

Placebo

A sunflower oil placebo containing 380 mg of sunflower oil

Sponsors & Collaborators

  • MacuHealth

    collaborator INDUSTRY

  • Orlando Regional Medical Center

    collaborator OTHER

  • Penn State University

    lead OTHER

Principal Investigators

  • Semyon Slobounov, PhD · The Pennsylvania State University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-11-22
Completion
2024-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270680 on ClinicalTrials.gov