Status:
COMPLETED
Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Pronova BioPharma
Conditions:
Inflammatory Responses
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate inflammatory responses to endotoxin challenge.
Detailed Description
Controlled endotoxin infusion has been used widely as a model system to evaluate anti-inflammatory mediators and therapies in a controlled, in vivo setting. It is well established that infusion of bac...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men between the ages of 20 and 45.
- BMI ≥20 and ≤30
- Participants who are able to give written informed consent and willing to comply with all study-related procedures.
- Any race or ethnic background is acceptable
- Non-smoking
- The specific exclusion criteria are:
- Previous history of vasovagal reactions or unprovoked fainting (I.e. fainting as a result of prolonged standing, exercise)
- Resting heart rate \< 55 bpm
- History of atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus (and/or a fasting glucose \>126 mg/dL at screening)
- Chronic anti-inflammatory medication use or treatment with aspirin, NSAIDs, COX-2 inhibitors; steroids or any immunomodulatory therapy 2 weeks prior to the screening visit
- Self-reported history of allergy to fish
- History of a non-skin malignancy within the previous 5 years
- Renal insufficiency as defined by creatinine outside of lab defined normal range at Screening Visit
- History of liver disease or abnormal LFTs (AST, ALT, Alk. Phos., GGT \> 1.5x ULN; bilirubin \> 2x ULN) at Screening Visit
- Total white blood cell count less than or equal to 3.0 THO/uL
- Hemoglobin less than 11.0 g/dL
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection
- Self-reported history of HIV positive
- Participants who have undergone any organ transplant
- Individuals who currently use tobacco products or have done so in the previous 30 days.
- Participants who are unwilling to discontinue use of nutritional supplements, herbs or vitamins unless approved by study staff.
- Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements and/or fortified food, or have a usual intake of high omega-3 fish (tuna and other non-fried fish) \> 2 servings per week
- Elevated blood pressure (BP \> 159/99) or use of any anti-hypertensive medications.
- Latex allergy
- Unwillingness to refrain from blood donation for 2 months prior to and following endotoxin administration
- Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
- Inability to take study capsules
- History of severe, repeated headaches
- History of migraine
- Medical condition that causes severe nausea or vomiting
- Low resting blood pressure (SBP \< 90 mmHg)
- History of atrial fibrillation/flutter
- Abnormal coagulation parameters (platelet count, prothrombin time with INR), documented coagulation abnormality, or use of anticoagulant medication
- High LDL-C (\> or = 160 mg/dL)
Exclusion
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01813110
Start Date
May 1 2014
End Date
April 1 2015
Last Update
August 21 2023
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802