Trial Outcomes & Findings for Nucleophilic Defense Against PM Toxicity (NEAT Trial) (NCT NCT03314987)
NCT ID: NCT03314987
Last Updated: 2026-01-06
Results Overview
circulating pro-angiogenic cells
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
299 participants
Primary outcome timeframe
3 months
Results posted on
2026-01-06
Participant Flow
Only screened participants with the lowest levels of endogenous carnosine (n=299) were invited to participate in the full study.
Participant milestones
| Measure |
L-carnosine
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
146
|
|
Overall Study
COMPLETED
|
140
|
133
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
L-carnosine
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
13
|
Baseline Characteristics
Nucleophilic Defense Against PM Toxicity (NEAT Trial)
Baseline characteristics by cohort
| Measure |
L-carnosine Group
n=153 Participants
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=146 Participants
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
153 Participants
n=9 Participants
|
146 Participants
n=6 Participants
|
299 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 12.4 • n=9 Participants
|
45.1 years
STANDARD_DEVIATION 12.4 • n=6 Participants
|
44.8 years
STANDARD_DEVIATION 12.2 • n=9 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=9 Participants
|
84 Participants
n=6 Participants
|
173 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=9 Participants
|
62 Participants
n=6 Participants
|
126 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=9 Participants
|
116 Participants
n=6 Participants
|
246 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=9 Participants
|
146 participants
n=6 Participants
|
299 participants
n=9 Participants
|
|
urinary carnosine levels
|
11.3 nmol/mg creatinine
STANDARD_DEVIATION 26.6 • n=9 Participants
|
12.7 nmol/mg creatinine
STANDARD_DEVIATION 17.6 • n=6 Participants
|
12.1 nmol/mg creatinine
STANDARD_DEVIATION 22.1 • n=9 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: For some participants in both groups, insufficient blood samples were collected or there were errors in processing and data collection. Thus, the n=130 for both groups does not match with number of participants in the study visit.
circulating pro-angiogenic cells
Outcome measures
| Measure |
L-carnosine
n=130 Participants
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=130 Participants
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Endothelial Progenitor Cells
|
0.0025 # cells per CD41 minus cells
Standard Error 0.0004
|
0.0027 # cells per CD41 minus cells
Standard Error 0.0007
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: For some participants, this data could not be collected, so the n does not equal the total number of participants.
index of arterial function
Outcome measures
| Measure |
L-carnosine
n=137 Participants
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=134 Participants
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Augmentation Index
|
122.6 percentage of pulse pressure
Standard Deviation 10.8
|
121.4 percentage of pulse pressure
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 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.index of endothelial damage
Outcome measures
| Measure |
L-carnosine
n=33 Participants
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=38 Participants
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Endothelial Microparticles
|
1057 microparticles per microliter
Standard Error 177
|
709 microparticles per microliter
Standard Error 69
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: For some participants, blood samples were not collected or there were errors in processing or data collection. Thus n=132 and 128 is less than total number of participants.
percentage of CD14 events that are co-stained with CD41 (platelet glycoprotein GPIIb); also levels of CD62P (P-selectin) expression
Outcome measures
| Measure |
L-carnosine
n=132 Participants
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=128 Participants
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Platelet Monocyte Aggregates
|
12.3 percent of events
Standard Error 0.65
|
10.8 percent of events
Standard Error 0.58
|
Adverse Events
L-carnosine Group
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Group
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L-carnosine Group
n=153 participants at risk
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=146 participants at risk
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Gastrointestinal disorders
diarhhea
|
0.65%
1/153 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
0.00%
0/146 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
|
Infections and infestations
yeast infection
|
0.65%
1/153 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
0.00%
0/146 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
|
Psychiatric disorders
anxiety/depression
|
0.00%
0/153 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
0.68%
1/146 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
|
Cardiac disorders
hypotension
|
0.65%
1/153 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
1.4%
2/146 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
Other adverse events
| Measure |
L-carnosine Group
n=153 participants at risk
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
L-carnosine: a naturally occurring di-peptide
|
Placebo Group
n=146 participants at risk
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
placebo: an identically appearing supplement
|
|---|---|---|
|
Nervous system disorders
tingling sensation
|
7.2%
11/153 • Number of events 11 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
2.1%
3/146 • Number of events 3 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
|
Gastrointestinal disorders
nausea
|
8.5%
13/153 • Number of events 13 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
8.9%
13/146 • Number of events 13 • a total of 5 months, from initial screening until one month after study completion
adverse events as per clinical trials definition Information on events collected from participant report and by clinical team
|
Additional Information
Dr. Timothy O'Toole Associate Professor
University of Louisville
Phone: 15024190808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place