Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation

Completed · Not applicable · Has a placebo group

Conditions studied: Inflammatory Responses

In brief

The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate inflammatory responses to endotoxin challenge.

Key facts

Study ID

NCT01813110

Run by

Penn State University

People needed

21

Starts

2014-05-01

Expected to finish

2015-04-01

Last updated by the study team

2023-08-21

Who can join

Age: 20 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Penn State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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