A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Omega-Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Omega-Score
Time Frame: Change from Baseline in Omega-Score at 28 days
The 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 Outcomes
- Lipemic IndexTM(Change from Baseline in Lipemic Index at 28 days)