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Completed

NCT Number: NCT06270680

Carotenoids for Collision Athletes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

Originally adapted to augment macular pigment for anti-inflammatory, antioxidative, blue light, and visual performance purposes, supplementation with carotenoids has been tested in animal models for protective effects against traumatic brain injury (TBI). Results have been promising, as mice provided with the three main carotenoids (Lutein, Meso-Zeaxanthin, and Zeaxanthin) following TBI displayed reduced levels of pro-inflammatory markers (IL-1β, IL-6, and GFAP) and increased levels of GAP43, NCAM, and BDNF, signaling activation of anti-oxidant systems.

Due to inflammation of the visual system following trauma, immune responses in the eye are for both reparative and protective purposes. However, cytokines released by immune cells compromise visual acuity by means of inflammation and fibrosis (scarring). As such, inflammation to the visual system (including visual processing structures in the brain) carries the danger of visual impairment. Research examining chronic inflammatory responses in the optic tract and subsequent visual dysfunction found mTBI in rodent models to increase GFAP, tumor necrosis factor (TNF), and degeneration of axons up to 3.5 months post-injury. As such, inflammation of the visual system is a measurable phenomenon in rodent models, conveying the need for human subjects research. The nutrients found in the proposed test supplement, lutein, zeaxanthin, meso-zeaxanthin, along with the omega-3 fatty acids DHA and EPA, are deposited in the brain regions that are often found to be affected by a collision-related head injury. Thus, an exploratory study of this topic is proposed, utilizing the three main carotenoids in the form of a MacuHealth supplement.

Optical Coherence Tomography has become a critical clinical tool when discovering and diagnosing disease and neurological disorders of the eyes. It works to map the retina in order to give ophthalmologists precise measurements of the tissues which make up this important part of human anatomy and helps medical experts to diagnosis diseases of the eye such as Glaucoma and Macular Degeneration. In terms of retinal nerve fiber layer thickness (RNFL), a study found Olympic boxers to have thinner RNFL compared to controls. Another study found RNFL thickness as a significant predictor of athlete vs control status, with 4.8-um of thinning seen on average in athletes (boxing, football) when compared to controls.

Although vision disorders are so common, VQOL - to our knowledge - is not specifically addressed following exposure to repetitive head impacts (RHI), concussion, or during return-to-play protocol. In sports such as football, hockey, and boxing where participants are exposed to RHI, participation while experiencing decreased VQOL or visual functionality could prove costly to the health of those athletes. Poor visual acuity and photophobia following concussion have been cited as indicators of poor VQOL. As such, use of the VFQ-25 and the 10-Item Supplement may be important additions to current clinical practice when evaluating the baseline health status of athletes, and following the completion of a collision-sport season.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Collision sport athletes:
  • Penn State student ages 18 and over
  • Any gender
  • Participating in club, or intramural collision-sports and is willing to participate in this study (examples: hockey, lacrosse, soccer, wrestling, rugby, boxing, basketball, cheer).

Exclusion criteria

  • For all subjects:
  • Subjects with concurrent injury that would impair their ability to perform the assigned procedures will be excluded.
  • Under 18 years of age.
  • Not a Penn State Student
  • Not participating in a collision sport.
  • Diagnosis of a learning disability impacting their capacity to consent.
  • History of ocular or neurological disease (glaucoma, macular degeneration, MS, Parkinson's)
  • Concussion diagnosis within the last calendar year.
  • However, if a subject sustains a concussion during the course of the study, they may remain as an active participant if they wish to do so.

Treatment and study plan

Vision Edge Pro

Drug

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 names: Carotenoid supplement

Placebo

Other

A sunflower oil placebo containing 380 mg of sunflower oil

Primary outcomes

  1. Blood and saliva biomarkers via venous blood draw and spitting into sterile cup.

    Time frame: Up to 16 weeks

    • To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on blood and saliva biomarkers following a single competitive season of collegiate collision sport. Specific markers will include GFAP, NF-L, UCH-L1, SBDP, Tau, S100B, BDNF, IL-1B, IL-6.
  2. Visual Performance: Speed of visual processing

    Time frame: Up to 16 weeks

    • To assess the visual performance parameter of speed of visual processing, measured in hertz (Hz). Measured using a densitometer.
  3. Visual Performance: Contrast Sensitivity

    Time frame: Up to 16 weeks

    • To assess visual performance parameter of contrast sensitivity, measured by the percentage threshold of contrast reached using M&S Technologies Smart System Software.
  4. Skin carotenoid concentration

    Time frame: Up to 16 weeks

    • To measure skin carotenoid concentration to ensure compliance and bioavailability of the test supplement.
  5. Retinal Nerve Fiber Layer Thickness

    Time frame: Up to 16 weeks

    • Utilize Optical Coherence Tomography to examine changes in retinal nerve fiber layer thickness (RNFL) following exposure to repetitive head impacts during a single competitive season of collision sports.
  6. Macular Pigment Optical Density

    Time frame: Up to 16 weeks

    • To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on macular pigment optical density (MPOD) following supplementation over the course of a collegiate season. This is the measurement of blue light reduction by macular pigment, related to the amount of macular pigment carotenoids in an individual's body. Measured using densitometer.
  7. Visual Quality of Life Scores

    Time frame: Up to 16 weeks

    • To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25). Scale title: The National Eye Institute 25-Item Viual Function Questionnaire; minimum value of 0, maximum value of 100; higher score means a better outcome.
  8. Visual Quality of Life Scores

    Time frame: Up to 16 weeks

    • To explore the effect of Lutein, Meso-Zeaxanthin, and Zeaxanthin supplementation on self-reported measures of visual quality of life (VQOL) using the 10-Item Neuro-Ophthalmic Supplement (10-Item Supplement). Scale title: Ten Item Neuro-Ophthalmic Supplement; minimum value of 0, maximum value of 100; higher score means a better outcome.

Secondary outcomes

  1. Demographic information

    Time frame: Up to 16 weeks

    Secondary endpoints that will be measured are headache or migraine history, history of learning disability, dyslexia, ADD/ADHD, self- and family-history of psychiatric disorder. Recorded with yes or no answers.

  2. Demographic information

    Time frame: Up to 16 weeks

    Secondary endpoints that will be measured are duration of sport participation each week, measured in minutes.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • MacuHealth
  • Orlando Regional Medical Center

Registry information

Official study title

Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport Athletes

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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