Body Weight, Aspirin Dose and Pro-resolving Mediators

Phase 4

Completed

• Conditions: Body Weight
• Interventions: Drug: Aspirin 81mg; Drug: Aspirin 325mg

• Registration Number: NCT04697719
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-11-04
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aspirin 81mg, Then Aspirin 325mg	Aspirin 81mg	After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
Aspirin 81mg, Then Aspirin 325mg	Aspirin 325mg	After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
Aspirin 325mg, Then Aspirin 81mg	Aspirin 81mg	After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.
Aspirin 325mg, Then Aspirin 81mg	Aspirin 325mg	After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Serum 15R-LXA4	Week 9, Week 12

Secondary Outcome Measures

Name	Time	Method
Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)	Week 9, Week 12
Change in lipid mediator profile of leukotrienes	Week 9, Week 12
Change in platelet-monocyte aggregates	Week 9, Week 12
Change in lipid mediator profile of prostaglandins	Week 9, Week 12
Change in platelet-neutrophil aggregates	Week 9, Week 12
Change in platelet surface expression of CD62P	Week 9, Week 12
Change in leukocyte expression of ALX/FPR2	Week 9, Week 12
Change in leukocyte expression of GPR32	Week 9, Week 12
Change in leukocyte expression of ERV1/ChemR23	Week 9, Week 12
Change in leukocyte expression of BLT1	Week 9, Week 12

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States