NCT03314987

Nucleophilic Defense Against PM Toxicity (NEAT Trial)

Nucleophilic Defense Against PM Toxicity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

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.

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 participants from the Louisville metropolitan and neighboring areas will be randomized into two dietary supplement study groups - carnosine (n=120) versus placebo (n=120). Intervention of study dietary supplements will occur from May through September, when the levels of PM2.5.are highest in the Louisville, KY area. Study participants will be given a daily oral dose of total of 2 grams of carnosine (or placebo) for a total of 12 consecutive weeks (during May through September). Urinary levels of carnosine will be used to screen and identify potential candidates with low carnosine levels. Those with levels less than the median levels of the population, will be invited to participate in the study. The following measurements will be performed - blood and urine sample collection, physical examination, arterial stiffness, physical function, and self-reported surveys on environmental exposure, sleep, diet, and exercise. Supplement intervention (carnosine or placebo) will be initiated at the time of Baseline Assessment and will continue for 12 weeks from that date. Two follow up visits will occur at 6 weeks and 12 weeks respectively after initiating supplementation. This innovative clinical investigation will provide an insight into the pre and post intervention effects of a cheap, safe, and over-the-counter available dietary supplement in countering the effects of air pollution.

Conditions

• Air Pollution Toxicity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-carnosine	a naturally occurring di-peptide
OTHER	placebo	an identically appearing supplement

Timeline

• Start date: 2018-04-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2017-10-19
• Last updated: 2026-01-06
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States