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A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products

A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960660
Enrollment
35
Registered
2013-10-10
Start date
2012-05-31
Completion date
2013-06-30
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparative Bioavailability

Keywords

Fish Oil, EPA, DHA, Omega-Score, Lipemic Index, ethyl esters, triglycerides, phospholipids

Brief summary

Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques. The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.

Interventions

DIETARY_SUPPLEMENTOmega-3 Fatty Acids

Sponsors

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
CollaboratorNETWORK
Nordic Pharma, USA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participant is fluent in English * Participant understands the study requirements and is willing to comply with the protocol * Participant is willing to provide written informed consent * Participant is 18 years of age or older

Exclusion criteria

* Unwilling or unable to provide written consent * Participant has taken omega-3 supplements in the last 3 months * Participants consumes fish on a regular basis (more than 1 serving per week) * Females who are pregnant or breastfeeding * Participant has an allergy to fish or seafood * Participant has been diagnosed with any medical illness or conditions * Participant has a history of drug dependence or substance abuse (excluding nicotine) * Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates) * Individual has difficulty giving multiple blood samples

Design outcomes

Primary

MeasureTime frameDescription
Omega-ScoreChange from Baseline in Omega-Score at 28 daysThe Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.

Secondary

MeasureTime frameDescription
Lipemic IndexTMChange from Baseline in Lipemic Index at 28 daysThe Lipemic Index™ is the post-prandial rise in TG levels over a 5-hour period, following the consumption drink containing a measured amount of fat, carbohydrate and protein.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026