Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
31 participants
INTERVENTIONAL
2024-08-01
2024-11-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Supplement Group
The group receiving the carotenoid supplement.
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.
Placebo Group
The group receiving the placebo.
Placebo
A sunflower oil placebo containing 380 mg of sunflower oil
Interventions
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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.
Placebo
A sunflower oil placebo containing 380 mg of sunflower oil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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MacuHealth
INDUSTRY
Orlando Regional Medical Center
OTHER
Penn State University
OTHER
Responsible Party
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Semyon M. Slobounov, Ph.D.
Professor of Kinesiology
Principal Investigators
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Semyon Slobounov, PhD
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
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The Pennsylvania State University
University Park, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
Chen JJ, Bhatti MT. Papilledema. Int Ophthalmol Clin. 2019 Summer;59(3):3-22. doi: 10.1097/IIO.0000000000000274. No abstract available.
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.
Strong J. Retinal OCT Imaging - Ophthalmic Photographers' Society. Published 2011. Accessed January 5, 2023. https://www.opsweb.org/page/RetinalOCT
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.
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.
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.
Other Identifiers
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STUDY00023019
Identifier Type: -
Identifier Source: org_study_id
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