N/A
N=299
Nucleophilic Defense Against PM Toxicity (NEAT Trial)
Air Pollution Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT03314987 ↗Enrolled (actual)
299
Serious AEs
2.0%
Results posted
Jun 2024
Primary outcome: Primary: Endothelial Progenitor Cells — 0.0025; 0.0027 # cells per CD41 minus cells
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- L-carnosine (Dietary_supplement); placebo (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Progenitor Cells |
0.0025; 0.0027 | — |
| SECONDARY Augmentation Index |
122.6; 121.4 | — |
| SECONDARY Endothelial Microparticles |
1057; 709 | — |
| SECONDARY Platelet Monocyte Aggregates |
12.3; 10.8 | — |
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 and air pollution exposure induces a state of oxidative stress, the purpose of this study is to see if those taking carnosine as a dietary supplement are protected from air pollution-induced oxidative stress and adverse cardiovascular outcomes.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03314987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.