Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270680
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-03
Brief Title:
Carotenoids for Collision Athletes
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport Athletes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 35 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 48-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
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 35 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 48-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None