Trial record 18 of 216 for:    Open Studies | "Fatty Acids, Omega-3"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Penn State University
Sponsor:
Collaborator:
Pronova BioPharma
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT01813110
First received: March 14, 2013
Last updated: July 10, 2014
Last verified: July 2014
  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:


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


Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: April 2015
Estimated 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
Genders 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
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

Contacts
Contact: Ann C. Skulas-Ray, PhD 814-863-8056 aus164@psu.edu
Contact: Jennifer A. Fleming, MS, RD 814-863-8056 jas58@psu.edu

Locations
United States, Pennsylvania
Penn State University Recruiting
University Park, Pennsylvania, United States, 16802
Principal Investigator: Gordon L. Jensen, MD, PhD         
Sponsors and Collaborators
Penn State University
Pronova BioPharma
Investigators
Principal Investigator: Gordon Jensen, MD, PhD Penn State University
  More Information

No publications provided

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: July 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Penn State University:
inflammation
omega-3
fish oil

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014