Nucleophilic Defense Against PM Toxicity (NEAT Trial)

• Sponsor: University of Louisville (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03314987
• Collaborator: National Institute of Environmental Health Sciences (NIEHS) (NIH)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 4

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Air Pollution Toxicity	Dietary Supplement: L-carnosine; Other: placebo	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: placebo controlled, randomized, double-blindplacebo controlled, randomized, double-blind
• Masking: Double (Participant, Investigator)
• Masking Description: double blind (participant, investigator)
• Primary Purpose: Basic Science
• Official Title: Nucleophilic Defense Against PM Toxicity
• Actual Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intervention group Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks	Dietary Supplement: L-carnosine; a naturally occurring di-peptide
Placebo Comparator: placebo group Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks	Other: placebo; an identically appearing supplement

Outcome Measures

Primary Outcome Measures

1. endothelial progenitor cells [3 months]

   circulating pro-angiogenic cells

Secondary Outcome Measures

1. arterial stiffness [3 months]

   index of arterial function

2. endothelial microparticles [3 months]

   index of endothelial damage

3. platelet monocyte aggregates [3 months]

   index of platelet activation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trials Unit	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• National Institute of Environmental Health Sciences (NIEHS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• O'Toole TE, Hellmann J, Wheat L, Haberzettl P, Lee J, Conklin DJ, Bhatnagar A, Pope CA 3rd. Episodic exposure to fine particulate air pollution decreases circulating levels of endothelial progenitor cells. Circ Res. 2010 Jul 23;107(2):200-3. doi: 10.1161/CIRCRESAHA.110.222679. Epub 2010 Jul 1.

• Responsible Party: Timothy Edward O'Toole, Associate Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT03314987
• Other Study ID Numbers: 20.0258; 5R01ES019217
• First Posted: Oct 19, 2017
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Timothy Edward O'Toole, Associate Professor, University of Louisville: air pollution; oxidative stress; intervention

Study Results

No Results Posted as of Jan 24, 2022