Body Weight, Aspirin Dose and Pro-resolving Mediators

Body Weight Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04697719
• Other study ID #: 20-01884
• Status: Recruiting
• Phase: Phase 4
• Start date: November 4, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Sean Heffron, MD
• Phone: 212-263-0855
• Email: sean.heffron[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 31, 2025
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight

Intervention

Drug:
• Aspirin 81mg
81mg oral capsule
• Aspirin 325mg
325mg oral capsule

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum 15R-LXA4		Week 3, Week 6
Primary	Change in Serum 15R-LXA4		Week 9, Week 12
Secondary	Change in serum and neutrophil supernatant lipid mediators		Week 3, Week 6
Secondary	Change in serum and neutrophil supernatant lipid mediators		Week 9, Week 12
Secondary	Change in platelet-monocyte aggregates		Week 3, Week 6
Secondary	Change in platelet-monocyte aggregates		Week 9, Week 12
Secondary	Change in platelet-neutrophil aggregates		Week 3, Week 6
Secondary	Change in platelet-neutrophil aggregates		Week 9, Week 12
Secondary	Change in platelet surface expression of CD62P		Week 3, Week 6
Secondary	Change in platelet surface expression of CD62P		Week 9, Week 12
Secondary	Change in leukocyte expression of ALX/FPR2		Week 3, Week 6
Secondary	Change in leukocyte expression of ALX/FPR2		Week 9, Week 12
Secondary	Change in leukocyte expression of GPR32		Week 3, Week 6
Secondary	Change in leukocyte expression of GPR32		Week 9, Week 12
Secondary	Change in leukocyte expression of ERV1/ChemR23		Week 3, Week 6
Secondary	Change in leukocyte expression of ERV1/ChemR23		Week 9, Week 12
Secondary	Change in leukocyte expression of BLT1		Week 3, Week 6
Secondary	Change in leukocyte expression of BLT1		Week 9, Week 12