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

NCT01813110 | Completed Results DMC

• 1 other identifier: PRONOVA
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Responses

Keywords

inflammation; omega-3; fish oil

Outcome Measures

Primary Outcomes (1)

• Change in C Reactive Protein (CRP)

  Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention

  24 hours post endotoxin administration, following each 8 week intervention

Secondary Outcomes (2)

• Tumor Necrosis Factor-α (TNF-α)

  2 hours post endotoxin administration, following each 8 week intervention

• Interleukin-6 (IL-6)

  2 hours post endotoxin administration, following each 8 week intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical olive oil capsules

Drug: Placebo

Omega-3

EXPERIMENTAL

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

Interventions

4 g prescription omega-3 concentrate DRUG

4 g/d prescription omega-3 fatty acid concentrate taken orally for 8-12 weeks

Also known as: Lovaza, Omacor

Omega-3

Placebo DRUG

olive oil

Also known as: No other name (control)

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• Pronova BioPharma: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Omacor

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Penny Kris-Etherton
• Organization: Pennsylvania State University

pmk3@psu.edu

814-863-2923

Study Officials

• Gordon Jensen, MD, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 21, 2023
• Results First Posted: August 1, 2017

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)