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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Nucleophilic Defense Against PM Toxicity (NEAT Trial)

Short name NEAT

NCTNCT03314987 (opens ClinicalTrials.gov in a new tab)Other id20.0258Other id5R01ES019217
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
299 participants (actual)
Sponsor
University of Louisville · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
1 Apr 2018
Primary completion
1 Nov 2022
Completion
1 Nov 2022
First posted
19 Oct 2017
Last update posted
6 Jan 2026
Conditions
Air Pollution Toxicity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020202120222023
  1. N/A

    NEAT

    NCT03314987

    1 Apr 2018 to 1 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • L-carnosineDietary supplement
  • placeboOther

Arms2

  • Active comparator

    intervention group

    Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks

  • Placebo comparator

    placebo group

    Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Endothelial Progenitor Cells

    Time frame · 3 months

    Registry description

    circulating pro-angiogenic cells

Secondary outcomes(3)

  1. Augmentation Index

    Time frame · 3 months

    Registry description

    index of arterial function

  2. Endothelial Microparticles

    Time frame · Samples were collected from each participant at baseline, after ~6wk of intervention, and after ~12wk of intervention. Measurement will be performed on archived samples once assay is in place.

    Registry description

    index of endothelial damage

  3. Platelet Monocyte Aggregates

    Time frame · 3 months

    Registry description

    percentage of CD14 events that are co-stained with CD41 (platelet glycoprotein GPIIb); also levels of CD62P (P-selectin) expression

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Endothelial Progenitor Cells

GroupValue (# cells per CD41 minus cells)Spread
L-carnosine0.00250.0004
Placebo Group0.00270.0007
Secondary and other outcome results(3)
Secondary outcomeMean· 3 months

Augmentation Index

GroupValue (percentage of pulse pressure)Spread
L-carnosine Group122.610.8
Placebo Group121.410.4
Secondary outcomeMean· Samples were collected from each participant at baseline, after ~6wk of intervention, and after ~12wk of intervention. Measurement will be performed on archived samples once assay is in place.

Endothelial Microparticles

GroupValue (microparticles per microliter)Spread
L-carnosine1057177
Placebo70969
Secondary outcomeMean· 3 months

Platelet Monocyte Aggregates

GroupValue (percent of events)Spread
L-carnosine12.30.65
Placebo10.80.58

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
L-carnosine GroupEach participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks L-carnosine: a naturally occurring di-peptide0 / 1533 / 15324 / 153
Placebo GroupEach participant will be given a daily oral dose of 2 grams of placebo for 12 weeks placebo: an identically appearing supplement0 / 1463 / 14616 / 146

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

9 results

Evaluation of supplementary carnosine accumulation and distribution: an initial analysis of participants in the Nucleophilic Defense Against PM Toxicity (NEAT) clinical trial.

Baba et al. 2024Amino acidscited by 9

PMID 39215872PMC11365863DOI 10.1007/s00726-024-03414-5PUB-39215872

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Indexing hint: Clinical trial · 2020

Protocol to assess the efficacy of carnosine supplementation in mitigating the adverse cardiovascular responses to particulate matter (PM) exposure: the Nucleophilic Defense Against PM Toxicity (NEAT) trial.

O'Toole et al. 2020BMJ opencited by 4

PMID 33372072PMC7772308DOI 10.1136/bmjopen-2020-039118PUB-33372072

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBarski OA, Xie Z, Baba SP, Sithu SD, Agarwal A, Cai J, Bhatnagar A, Srivastava S. Dietary carnosine prevents early atherosclerotic lesion formation in apolipoprotein E-null mice. Arterioscler Thromb Vasc Biol. 2013 Jun;33(6):1162-70. doi: 10.1161/ATVBAHA.112.300572. Epub 2013 Apr 4. PMID 23559625
  • ResultPope CA 3rd, Bhatnagar A, McCracken JP, Abplanalp W, Conklin DJ, O'Toole T. Exposure to Fine Particulate Air Pollution Is Associated With Endothelial Injury and Systemic Inflammation. Circ Res. 2016 Nov 11;119(11):1204-1214. doi: 10.1161/CIRCRESAHA.116.309279. Epub 2016 Oct 25. PMID 27780829

Eligibility

Who could join, as posted.

Sex
All
Age
from 22 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Individuals between 22-65 years of age of either gender and all ethnicities, 2. All genders and all ethnicities 3. Residing in or near the Louisville metropolitan area 4. Consumes some type of meat/fish at least once a month during the past 3 months 5. Carnosine levels below the median level of the population 6. Agrees to complete all study visits and follow study intervention regimen 7. Will be living in the study area throughout the study period, with no more than 1 week away from the study area. Exclusion Criteria: 1. Consumed any dietary supplement more than 3 times per week in the past 4 weeks (one month) 2. Current / ongoing treatment for substance abuse 3. Currently undergoing treatment or have conditions which may cause participant to be immunosuppressed 4. 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.) 5. Diseases Affecting Bone Marrow capacity 6. Diagnosis of any active cancer 7. Recent organ / kidney transplant or replacement (Active/Long-Term Medications) 8. Type 1 Diabetes Mellitus 9. Untreated thyroid disease 10. Untreated anemia 11. Current acute infections (Influenza, fever, etc.) 12. HIV positive status 13. Active/current Hepatitis HepA, HepB or HepC or in past 6 months 14. Currently or planning to be Pregnant / lactating 15. Prisoners / vulnerable populations 16. Other medical conditions that compromise completion of study 17. Unwilling to provide consent

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