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临床试验/NCT06270680
NCT06270680已完成早期 1 期

Efficacy of Carotenoids on Blood Biomarkers Following a Collision Sport Athletes

Penn State University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
31
试验地点
1
主要终点
Skin carotenoid concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Supplement Group

Experimental

The group receiving the carotenoid supplement.

干预措施: Vision Edge Pro (Drug)

Placebo Group

Placebo Comparator

The group receiving the placebo.

干预措施: Placebo (Other)

结局指标

主要结局

Skin carotenoid concentration

时间窗: Up to 16 weeks

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

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

时间窗: 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.

Visual Performance: Speed of visual processing

时间窗: Up to 16 weeks

2. To assess the visual performance parameter of speed of visual processing, measured in hertz (Hz). Measured using a densitometer.

Visual Performance: Contrast Sensitivity

时间窗: 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.

Visual Quality of Life Scores

时间窗: 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.

Retinal Nerve Fiber Layer Thickness

时间窗: 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.

Macular Pigment Optical Density

时间窗: 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.

次要结局

  • Demographic information(Up to 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Semyon M. Slobounov, Ph.D.

Professor of Kinesiology

Penn State University

研究点 (1)

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