N/A
N=21
Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation
Inflammatory Responses
Bottom Line
View on ClinicalTrials.gov: NCT01813110 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Change in C Reactive Protein (CRP) — 17.2; 17.1 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4 g prescription omega-3 concentrate (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Penn State University
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in C Reactive Protein (CRP) |
17.2; 17.1 | — |
| SECONDARY Tumor Necrosis Factor-α (TNF-α) |
58.3; 59.9 | — |
| SECONDARY Interleukin-6 (IL-6) |
90.6; 99.9 | — |
Summary
The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate inflammatory responses to endotoxin challenge.
Eligibility Criteria
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 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 or = 160 mg/dL)
Data sourced from ClinicalTrials.gov (NCT01813110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.