Clinical trial

Efficacy of Carotenoids on Blood Biomarkers Following A Collision Sport Athletes

Name
STUDY00023019
Description
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.
Trial arms
Trial start
2024-08-01
Estimated PCD
2024-12-20
Trial end
2024-12-20
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Supplement Group
Other names:
Carotenoid supplement
Placebo
A sunflower oil placebo containing 380 mg of sunflower oil
Arms:
Placebo Group
Size
52
Primary endpoint
Blood and saliva biomarkers via venous blood draw and spitting into sterile cup.
Up to 16 weeks
Visual Performance: Speed of visual processing
Up to 16 weeks
Visual Performance: Contrast Sensitivity
Up to 16 weeks
Skin carotenoid concentration
Up to 16 weeks
Retinal Nerve Fiber Layer Thickness
Up to 16 weeks
Macular Pigment Optical Density
Up to 16 weeks
Visual Quality of Life Scores
Up to 16 weeks
Visual Quality of Life Scores
Up to 16 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2024-03-18

1 organization

1 product

2 indications

Indication
Head Injury
Indication
Carotenoids