Clinical trial NCT02628483: A Comparator Trial on the Relative Efficacy of Two Triglyceride Forms of Fish Oil
Official title: A Randomized, Double-blind, Parallel Clinical Trial to Compare the Relative Efficacy of Two Triglyceride Forms of Fish Oil, Ultimate Omega®, and a Comparator Product, in Improving Red Blood Cell Fatty Acid Profiles in Healthy Adults (FORCE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Nordic Pharma, USA
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2015-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The health benefits of omega-3 fatty acids have been extensively examined in many published studies, and these benefits have been observed in patients with a diversity of conditions and diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis, thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline, periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to healthy individuals, in terms of preventative health benefits. The balance between omega-6 long chain fatty acids and their omega-3 counterparts is important in health maintenance. An omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014 study of the dietary habits of U.S. adults revealed that, in general, North Americans do not meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to be considered, in order to help this population meet their daily needs. Both the Academy of Nutrition and Dietetics and the American Heart Association suggest a prudent approach in recommending an increased intake of omega-3 fatty acids. Although both organisations recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also recognise that supplementation may also be required in order to meet target values, particularly in at-risk populations.

Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA and DHA and are available in varying forms including ethyl ester and high triglyceride forms. Differences in product formulation have been shown to have varying health effects.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged 18 - 35 (inclusive)
* Healthy as determined from medical history
* Non-smoker, or ex-smoker ≥6 months
* Body mass index 18.5 - 24.9 kg/m2
* Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative urine pregnancy test and must be using an effective birth control method
* Willing to avoid alcohol consumption for 24 h prior to every clinic visit
* Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
* Willing and able to provide informed written consent

Exclusion Criteria:

* Individuals taking prescription or non-prescription health products that may affect the study endpoint (e.g. corticosteroids, prescription anti-inflammatory drugs, blood lipid-lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, etc.) in the previous 6 months
* Individuals taking any supplements with omega-3 fatty acids, phytosterols, polyglucosamines (Chitosan) or other lipid-binding ingredients in the previous 6 months
* Individuals who consume omega-3 fatty acid rich fish (salmon, mackerel, herring) more than twice per month
* Unstable use (initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
* Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study
* Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study
* History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
* Presence of major diseases such as diabetes, gastrointestinal, endocrine, cardiovascular, renal, or liver disease
* History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
* History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in past 5 years
* Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
* Abnormal laboratory test results of clinical significance, including, but not limited to, ALT or AST ≥1.5X the upper limit of normal at screening (visit 1)
* Triglycerides ≥400 mg/dL (≥4.52mmol/L) at screening (visit 1)
* Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of \>2 standard alcoholic drinks per day
* Participant has a known allergy or intolerance to fish/fish oil or any of the ingredients in the test products
* Participant is vegan
* Participant is unwilling or unable to abide by the requirements of the protocol
* Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
* Participant has taken an investigational medicine or has participated in a research study within 30 days prior to the first study visit

Primary outcomes:
measure: Red blood cell EPA and DHA
timeFrame: 24 weeks
measure: Phospholipid EPA and DHA
timeFrame: 4 weeks
Secondary outcomes:
measure: Red blood cell EPA and DHA
timeFrame: 12 and 16 weeks
measure: Lipid profile
timeFrame: 24 weeks
Other outcomes:
measure: Safety Anthropometric Measurements
timeFrame: 4, 12, 16 and 24 weeks
measure: Safety blood parameters
timeFrame: 24 weeks
measure: Adverse Events
timeFrame: 24 weeks
Locations:
city: Guelph
country: Canada
facility: Nutrasource
state: Ontario
Study officials:
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: Anthony Bier, MD
role: PRINCIPAL_INVESTIGATOR
References: