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

Purpose

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

Condition	Intervention
Inflammatory Responses	Drug: 4 g prescription omega-3 concentrate Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effects of a Prescription Omega-3 Fatty Acid Concentrate in a Placebo-controlled Trial of Human Endotoxemia

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Change in C reactive protein (CRP) [ Time Frame: 24 hours post endotoxin administration ] [ Designated as safety issue: No ]
Change in blood levels of CRP at 24 hours post endotoxin administration

Secondary Outcome Measures:

Prostaglandin J3 [ Time Frame: 7 days post endotoxin challenge ] [ Designated as safety issue: No ]
Changes in plasma levels of prostaglandin J3 resulting from omega-3 supplementation and induced inflammation


Enrollment:	21
Study Start Date:	May 2014
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Identical olive oil capsules	Drug: Placebo
Experimental: Omega-3 4 g prescription omega-3 concentrate (4 g/d prescription omega-3 fatty acid concentrate taken orally for 8-12 weeks)	Drug: 4 g prescription omega-3 concentrate 4 g/d prescription omega-3 fatty acid concentrate taken orally for 8-12 weeks Other Names: Lovaza Omacor

Eligibility


Ages Eligible for Study:	20 Years to 45 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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 < 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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813110

Locations


United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

Pronova BioPharma

Investigators


Principal Investigator:	Gordon Jensen, MD, PhD	Penn State University

More Information


Responsible Party:	Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier:	NCT01813110 History of Changes
Other Study ID Numbers:	PRONOVA
Study First Received:	March 14, 2013
Last Updated:	May 21, 2015
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Penn State University:


inflammation omega-3 fish oil

ClinicalTrials.gov processed this record on September 30, 2016

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