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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813110
First Posted: March 18, 2013
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pronova BioPharma
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
  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: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Penny Kris-Etherton, Penn State University:

Primary Outcome Measures:
  • Change in C Reactive Protein (CRP) [ Time Frame: 24 hours post endotoxin administration, following each 8 week intervention ]
    Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention


Secondary Outcome Measures:
  • Prostaglandin J3 [ Time Frame: 7 days post endotoxin challenge ]
    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

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Men between the ages of 20 and 45.
  2. BMI ≥20 and ≤30
  3. Participants who are able to give written informed consent and willing to comply with all study-related procedures.
  4. Any race or ethnic background is acceptable
  5. Non-smoking

The specific exclusion criteria are:

  1. Previous history of vasovagal reactions or unprovoked fainting (I.e. fainting as a result of prolonged standing, exercise)
  2. Resting heart rate < 55 bpm
  3. History of atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
  4. History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening)
  5. 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
  6. Self-reported history of allergy to fish
  7. History of a non-skin malignancy within the previous 5 years
  8. Renal insufficiency as defined by creatinine outside of lab defined normal range at Screening Visit
  9. History of liver disease or abnormal LFTs (AST, ALT, Alk. Phos., GGT > 1.5x ULN; bilirubin > 2x ULN) at Screening Visit
  10. Total white blood cell count less than or equal to 3.0 THO/uL
  11. Hemoglobin less than 11.0 g/dL
  12. Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection
  13. Self-reported history of HIV positive
  14. Participants who have undergone any organ transplant
  15. Individuals who currently use tobacco products or have done so in the previous 30 days.
  16. Participants who are unwilling to discontinue use of nutritional supplements, herbs or vitamins unless approved by study staff.
  17. 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
  18. Elevated blood pressure (BP > 159/99) or use of any anti-hypertensive medications.
  19. Latex allergy
  20. Unwillingness to refrain from blood donation for 2 months prior to and following endotoxin administration
  21. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
  22. Inability to take study capsules
  23. History of severe, repeated headaches
  24. History of migraine
  25. Medical condition that causes severe nausea or vomiting
  26. Low resting blood pressure (SBP < 90 mmHg)
  27. History of atrial fibrillation/flutter
  28. Abnormal coagulation parameters (platelet count, prothrombin time with INR), documented coagulation abnormality, or use of anticoagulant medication
  29. High LDL-C (> or = 160 mg/dL)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 14, 2013
First Posted: March 18, 2013
Results First Submitted: May 23, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Penny Kris-Etherton, Penn State University:
inflammation
omega-3
fish oil