Status:
COMPLETED
Nucleophilic Defense Against PM Toxicity (NEAT Trial)
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Air Pollution Toxicity
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
Carnosine is a naturally occurring peptide found in high levels in skeletal muscle and the brain and is also available commercially as a dietary supplement. Since carnosine has anti-oxidant properties...
Detailed Description
This is a placebo controlled, randomized, double-blind, interventional trial investigating the efficacy of carnosine in reducing the effects of particulate matter air pollution (PM2.5). A total of 240...
Eligibility Criteria
Inclusion
- Individuals between 22-65 years of age of either gender and all ethnicities,
- All genders and all ethnicities
- Residing in or near the Louisville metropolitan area
- Consumes some type of meat/fish at least once a month during the past 3 months
- Carnosine levels below the median level of the population
- Agrees to complete all study visits and follow study intervention regimen
- Will be living in the study area throughout the study period, with no more than 1 week away from the study area.
Exclusion
- Consumed any dietary supplement more than 3 times per week in the past 4 weeks (one month)
- Current / ongoing treatment for substance abuse
- Currently undergoing treatment or have conditions which may cause participant to be immunosuppressed
- Diseases Affecting Peripheral Cell Count (i.e. Autoimmune Diseases - Hashimoto, Rheumatoid Arthritis, SLE, Rheumatoid Arthritis, Sjogren syndrome, Ankylosing Spondylitis, Takayasu arteritis, Kawasaki disease, Polyarteritis nodosa.)
- Diseases Affecting Bone Marrow capacity
- Diagnosis of any active cancer
- Recent organ / kidney transplant or replacement (Active/Long-Term Medications)
- Type 1 Diabetes Mellitus
- Untreated thyroid disease
- Untreated anemia
- Current acute infections (Influenza, fever, etc.)
- HIV positive status
- Active/current Hepatitis HepA, HepB or HepC or in past 6 months
- Currently or planning to be Pregnant / lactating
- Prisoners / vulnerable populations
- Other medical conditions that compromise completion of study
- Unwilling to provide consent
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT03314987
Start Date
April 1 2018
End Date
November 1 2022
Last Update
January 6 2026
Active Locations (1)
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1
Clinical Trials Unit
Louisville, Kentucky, United States, 40202