Nucleophilic Defense Against PM Toxicity (NEAT Trial)

What Was Tested

In this not phased trial, researchers set out to test Carnosine.

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.

It had two arms (groups): intervention group (active comparator) and placebo group (placebo comparator).

The registry classes the interventions as dietary supplement and other.

More on the Plan

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.

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.

Who Took Part

Enrollment: 299 actual participants took part.

It was open to people of any sex aged from 22 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Individuals between 22-65 years of age of either gender and all ethnicities,. All genders and all ethnicities. 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.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Carnosine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-04-01 with completion listed for 2022-11-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Endothelial Progenitor Cells (time frame: 3 months).

It also tracked 3 secondary outcomes, for example Augmentation Index, Endothelial Microparticles and Platelet Monocyte Aggregates.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 299 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Carnosine compound page, all human trials.