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

N/ACompletedNCT01960660

Nordic Pharma, USA35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Comparative Bioavailability

Interventions

Omega-3 Fatty AcidsDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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.

Time frame: Change from Baseline in Omega-Score at 28 days

Secondary Outcomes

Lipemic IndexTM

The 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.

Time frame: Change from Baseline in Lipemic Index at 28 days