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CompletedNCT02628483Updated Dec 14, 2016

A Comparator Trial on the Relative Efficacy of Two Triglyceride Forms of Fish Oil

A Phase 2 interventional study of Fish Oil and Fish Oil in Healthy Volunteers, sponsored by Nordic Pharma, USA. Completed at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-14.

Sponsored by Nordic Pharma, USA · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Nordic Pharma, USA is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Ultimate Omega

    5 capsules of Ultimate Omega fish oil daily in the morning with food

    Dietary Supplement: Fish Oil

  • Active comparator
    Meg-3

    5 capsules of Meg-3 fish oil daily in the morning with food

    Dietary Supplement: Fish Oil

Interventions

  • Dietary supplementFish Oil

    1000mg fish oil per capsule (325mg EPA + 225mg DHA)

    Also known as: Ultimate Omega

  • Dietary supplementFish Oil

    1000mg fish oil per capsule (300mg EPA + 200mg DHA)

    Also known as: Meg-3

06

What researchers measure

Primary outcomes

  1. Red blood cell EPA and DHA

    Time frame: 24 weeks

  2. Phospholipid EPA and DHA

    Time frame: 4 weeks

Secondary outcomes

  1. Red blood cell EPA and DHA

    Time frame: 12 and 16 weeks

  2. Lipid profile

    Total cholesterol, LDL-C, HDL-C and triglycerides

    Time frame: 24 weeks

Other outcomes

  1. Safety Anthropometric Measurements

    Blood pressure, Heart rate, Weight and BMI

    Time frame: 4, 12, 16 and 24 weeks

  2. Safety blood parameters

    Complete blood count, electrolytes, markers of kidney and liver function

    Time frame: 24 weeks

  3. Adverse Events

    Adverse events over the supplementation period

    Time frame: 24 weeks

07

Study locations

1 site
  • Nutrasource
    Guelph, Ontario N1G 0B4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02628483
Lead sponsor
Nordic Pharma, USA
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Dec 11, 2015
Start date
Feb 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 14, 2016

Study contacts

Anthony Bier, MD
principal investigator · Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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