Body Weight, Aspirin Dose and Pro-resolving Mediators

DISCOVER: A Single-site Double-blind Placebo-controlled Randomized Mechanistic Crossover Trial to Assess the Influence of boDy weIght on aSpirin-triggered speCialized prO-resolVing mEdiatoRs

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04697719

Enrollment

108

Registered

2021-01-06

Start date

2021-11-04

Completion date

2025-01-29

Last updated

2026-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight

Keywords

Aspirin

Brief summary

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.

Interventions

DRUGAspirin 81mg

81mg oral capsule

DRUGAspirin 325mg

325mg oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Intervention model description

This is a two-phase crossover design with run-in and wash out periods prior to each phase.

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Age between 40 and 70 years

Exclusion criteria

1. Anti-platelet medication use in the past 7 days 2. Aspirin intolerance or allergy 3. Known bleeding or clotting disorder 4. Chronic inflammatory or connective tissue disease 5. Immunological deficiency 6. Diabetes mellitus 7. Prior gastric or bariatric surgery 8. Active smoking 9. Platelet count \<100,000 10. Use of omega-3 fatty acid supplementation 11. Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases 12. Corticosteroid use 13. Recent initiation or change in dose of statin therapy 14. Pregnancy

Design outcomes

Primary

Measure	Time frame
Change in Serum 15R-LXA4	Week 3, Week 6

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSean Heffron, MD

NYU Langone Health

Baseline characteristics

Characteristic	—
Age, Continuous	50 years STANDARD_DEVIATION 7.7
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	8 Participants
Race (NIH/OMB) Black or African American	13 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	44 Participants
Region of Enrollment United States	84 participants
Sex: Female, Male Female	41 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 40	0 / 44
other Total, other adverse events	5 / 40	7 / 44
serious Total, serious adverse events	0 / 40	0 / 44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 28, 2026