Clinical trial NCT04697719: Body Weight, Aspirin Dose and Pro-resolving Mediators
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Weight
Keywords: Aspirin
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a two-phase crossover design with run-in and wash out periods prior to each phase.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Serum 15R-LXA4
timeFrame: Week 3, Week 6
measure: Change in Serum 15R-LXA4
timeFrame: Week 9, Week 12
Secondary outcomes:
measure: Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)
timeFrame: Week 3, Week 6
measure: Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)
timeFrame: Week 9, Week 12
measure: Change in lipid mediator profile of leukotrienes
timeFrame: Week 3, Week 6
measure: Change in lipid mediator profile of leukotrienes
timeFrame: Week 9, Week 12
measure: Change in lipid mediator profile of prostaglandins
timeFrame: Week 3, Week 6
measure: Change in lipid mediator profile of prostaglandins
timeFrame: Week 9, Week 12
measure: Change in platelet-monocyte aggregates
timeFrame: Week 3, Week 6
measure: Change in platelet-monocyte aggregates
timeFrame: Week 9, Week 12
measure: Change in platelet-neutrophil aggregates
timeFrame: Week 3, Week 6
measure: Change in platelet-neutrophil aggregates
timeFrame: Week 9, Week 12
measure: Change in platelet surface expression of CD62P
timeFrame: Week 3, Week 6
measure: Change in platelet surface expression of CD62P
timeFrame: Week 9, Week 12
measure: Change in leukocyte expression of ALX/FPR2
timeFrame: Week 3, Week 6
measure: Change in leukocyte expression of ALX/FPR2
timeFrame: Week 9, Week 12
measure: Change in leukocyte expression of GPR32
timeFrame: Week 3, Week 6
measure: Change in leukocyte expression of GPR32
timeFrame: Week 9, Week 12
measure: Change in leukocyte expression of ERV1/ChemR23
timeFrame: Week 3, Week 6
measure: Change in leukocyte expression of ERV1/ChemR23
timeFrame: Week 9, Week 12
measure: Change in leukocyte expression of BLT1
timeFrame: Week 3, Week 6
measure: Change in leukocyte expression of BLT1
timeFrame: Week 9, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sean Heffron, MD
role: PRINCIPAL_INVESTIGATOR
References: