Carotenoids for Collision Athletes

NCT06270680 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY00023019
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carotenoids; Brain injury; Head impacts; Vision

Outcome Measures

Primary Outcomes (8)

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

  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

  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

  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

  4\. To measure skin carotenoid concentration to ensure compliance and bioavailability of the test supplement.

  Up to 16 weeks

• Retinal Nerve Fiber Layer Thickness

  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

  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

  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

  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 Outcomes (2)

• Demographic information

  Up to 16 weeks

• Demographic information

  Up to 16 weeks

Study Arms (2)

Supplement Group

EXPERIMENTAL

The group receiving the carotenoid supplement.

Drug: Vision Edge Pro

Placebo Group

PLACEBO COMPARATOR

The group receiving the placebo.

Other: Placebo

Interventions

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.

Also known as: Carotenoid supplement

Supplement Group

Placebo OTHER

A sunflower oil placebo containing 380 mg of sunflower oil

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• MacuHealth: collaborator
• Orlando Regional Medical Center: collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (11)

• Stringham JM, Hammond BR. Macular pigment and visual performance under glare conditions. Optom Vis Sci. 2008 Feb;85(2):82-8. doi: 10.1097/OPX.0b013e318162266e.

  PMID: 18296924 BACKGROUND

• Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.

  PMID: 28661438 BACKGROUND

• Stringham JM, Johnson EJ, Hammond BR. Lutein across the Lifespan: From Childhood Cognitive Performance to the Aging Eye and Brain. Curr Dev Nutr. 2019 Jun 4;3(7):nzz066. doi: 10.1093/cdn/nzz066. eCollection 2019 Jul.

  PMID: 31321376 BACKGROUND

• Gunal MY, Sakul AA, Caglayan AB, Erten F, Kursun OED, Kilic E, Sahin K. Protective Effect of Lutein/Zeaxanthin Isomers in Traumatic Brain Injury in Mice. Neurotox Res. 2021 Oct;39(5):1543-1550. doi: 10.1007/s12640-021-00385-3. Epub 2021 Jun 15.

  PMID: 34129176 BACKGROUND

• Stepp MA, Menko AS. Immune responses to injury and their links to eye disease. Transl Res. 2021 Oct;236:52-71. doi: 10.1016/j.trsl.2021.05.005. Epub 2021 May 27.

  PMID: 34051364 BACKGROUND

• Chen JJ, Bhatti MT. Papilledema. Int Ophthalmol Clin. 2019 Summer;59(3):3-22. doi: 10.1097/IIO.0000000000000274. No abstract available.

  PMID: 31233413 BACKGROUND

• Vishwanathan R, Neuringer M, Snodderly DM, Schalch W, Johnson EJ. Macular lutein and zeaxanthin are related to brain lutein and zeaxanthin in primates. Nutr Neurosci. 2013 Jan;16(1):21-9. doi: 10.1179/1476830512Y.0000000024. Epub 2012 Jul 9.

  PMID: 22780947 BACKGROUND

• Strong J. Retinal OCT Imaging - Ophthalmic Photographers' Society. Published 2011. Accessed January 5, 2023. https://www.opsweb.org/page/RetinalOCT

  BACKGROUND

• Childs C, Barker LA, Gage AM, Loosemore M. Investigating possible retinal biomarkers of head trauma in Olympic boxers using optical coherence tomography. Eye Brain. 2018 Dec 14;10:101-110. doi: 10.2147/EB.S183042. eCollection 2018.

  PMID: 30588143 BACKGROUND

• Leong D, Morettin C, Messner LV, Steinmetz RJ, Pang Y, Galetta SL, Balcer LJ. Visual Structure and Function in Collision Sport Athletes. J Neuroophthalmol. 2018 Sep;38(3):285-291. doi: 10.1097/WNO.0000000000000572.

  PMID: 28885451 BACKGROUND

• Armstrong RA. Visual problems associated with traumatic brain injury. Clin Exp Optom. 2018 Nov;101(6):716-726. doi: 10.1111/cxo.12670. Epub 2018 Feb 28.

  PMID: 29488253 BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Semyon Slobounov, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 21, 2024
• Study Start: August 1, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)