Overview
The Effects of Omega-3 Fatty Acids on Aspirin Resistance
Status:
Completed
Completed
Trial end date:
2009-01-01
2009-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of RochesterCollaborators:
American College of Clinical Pharmacy
Cornell University
GlaxoSmithKlineTreatments:
Aspirin
Criteria
Inclusion Criteria:- Willing to participate by providing informed consent and committing to complete the
study. This includes adhering to the study diet.
- No chronic disease by history and based on a complete blood count and comprehensive
metabolic profile.
- Commitment to not taking aspirin, non-steroidal anti-inflammatory medications, and to
limit fish intake to ≤2 meals during the 7 days prior to each CRC study period. They
will also need to abstain from taking a list of over-the-counter medications that
include aspirin. For the duration of the study, they will also be asked to abstain
from taking fish and flax seed oil supplements.
Exclusion Criteria:
- Reports the presence of chronic disease (e.g. cardiovascular, renal, hepatic,
neurodegenerative, neoplastic, metabolic {diabetes}, hypertension).
- Reports taking a systemic medication chronically.
- History of serious adverse reaction or allergy to aspirin or fish oil.
- Baseline platelet count <100 000 or >500 000, hematocrit <30%, or white blood cell
count >20 000.
- Any abnormality from a screening CBC and complete blood count that suggests acute or
chronic disease.
- Nicotine user.
- History of alcohol abuse
- Pregnancy by history or urine/serum pregnancy test
- History of intestinal malabsorption syndrome including gastric bypass surgery