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Completed

NCT Number: NCT04697719

Body Weight, Aspirin Dose and Pro-resolving Mediators

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.

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Key information

Conditions

Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 40 and 70 years

Exclusion criteria

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

Treatment and study plan

Aspirin 81mg

Drug

81mg oral capsule

Aspirin 325mg

Drug

325mg oral capsule

Primary outcomes

  1. Change in Serum 15R-LXA4

    Time frame: Week 3, Week 6

  2. Change in Serum 15R-LXA4

    Time frame: Week 9, Week 12

Secondary outcomes

  1. Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)

    Time frame: Week 3, Week 6

  2. Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)

    Time frame: Week 9, Week 12

  3. Change in lipid mediator profile of leukotrienes

    Time frame: Week 3, Week 6

  4. Change in lipid mediator profile of leukotrienes

    Time frame: Week 9, Week 12

  5. Change in lipid mediator profile of prostaglandins

    Time frame: Week 3, Week 6

  6. Change in lipid mediator profile of prostaglandins

    Time frame: Week 9, Week 12

  7. Change in platelet-monocyte aggregates

    Time frame: Week 3, Week 6

  8. Change in platelet-monocyte aggregates

    Time frame: Week 9, Week 12

  9. Change in platelet-neutrophil aggregates

    Time frame: Week 3, Week 6

  10. Change in platelet-neutrophil aggregates

    Time frame: Week 9, Week 12

  11. Change in platelet surface expression of CD62P

    Time frame: Week 3, Week 6

  12. Change in platelet surface expression of CD62P

    Time frame: Week 9, Week 12

  13. Change in leukocyte expression of ALX/FPR2

    Time frame: Week 3, Week 6

  14. Change in leukocyte expression of ALX/FPR2

    Time frame: Week 9, Week 12

  15. Change in leukocyte expression of GPR32

    Time frame: Week 3, Week 6

  16. Change in leukocyte expression of GPR32

    Time frame: Week 9, Week 12

  17. Change in leukocyte expression of ERV1/ChemR23

    Time frame: Week 3, Week 6

  18. Change in leukocyte expression of ERV1/ChemR23

    Time frame: Week 9, Week 12

  19. Change in leukocyte expression of BLT1

    Time frame: Week 3, Week 6

  20. Change in leukocyte expression of BLT1

    Time frame: Week 9, Week 12

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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