Carotenoids for Collision Athletes

March 14, 2024 updated by: Semyon M. Slobounov, Ph.D., Penn State University

Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Semyon Slobounov, PhD
  • Phone Number: 8145714298
  • Email: sms18@psu.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University
        • Contact:
        • Contact:
          • Semyon Slobounov, PhD
          • Phone Number: 814-571-4298
          • Email: sms18@psu.edu
        • Principal Investigator:
          • Semyon Slobounov, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Collision sport athletes:

    1. Penn State student ages 18 and over
    2. Any gender
    3. 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:

    1. Subjects with concurrent injury that would impair their ability to perform the assigned procedures will be excluded.
    2. Under 18 years of age.
    3. Not a Penn State Student
    4. Not participating in a collision sport.
    5. Diagnosis of a learning disability impacting their capacity to consent.
    6. History of ocular or neurological disease (glaucoma, macular degeneration, MS, Parkinson's)
    7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement Group
The group receiving the carotenoid supplement.
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 Names:
  • Carotenoid supplement
Placebo Comparator: Placebo Group
The group receiving the placebo.
Other: Placebo
A sunflower oil placebo containing 380 mg of sunflower oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood and saliva biomarkers via venous blood draw and spitting into sterile cup.
Time Frame: Up to 16 weeks
1. 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.
Up to 16 weeks
Visual Performance: Speed of visual processing
Time Frame: Up to 16 weeks
2. To assess the visual performance parameter of speed of visual processing, measured in hertz (Hz). Measured using a densitometer.
Up to 16 weeks
Visual Performance: Contrast Sensitivity
Time Frame: Up to 16 weeks
3. To assess visual performance parameter of contrast sensitivity, measured by the percentage threshold of contrast reached using M&S Technologies Smart System Software.
Up to 16 weeks
Skin carotenoid concentration
Time Frame: Up to 16 weeks
4. To measure skin carotenoid concentration to ensure compliance and bioavailability of the test supplement.
Up to 16 weeks
Retinal Nerve Fiber Layer Thickness
Time Frame: Up to 16 weeks
5. 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.
Up to 16 weeks
Macular Pigment Optical Density
Time Frame: Up to 16 weeks
6. 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.
Up to 16 weeks
Visual Quality of Life Scores
Time Frame: Up to 16 weeks
7. 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.
Up to 16 weeks
Visual Quality of Life Scores
Time Frame: Up to 16 weeks
8. 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.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 16 weeks
Demographic information
Time Frame: Up to 16 weeks
Secondary endpoints that will be measured are duration of sport participation each week, measured in minutes.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Orlando Regional Medical Center
MacuHealth

Investigators

  • Principal Investigator: Semyon Slobounov, PhD, The Pennsylvania State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00023019 (OHSU Knight Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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