Clinical Trials Directory

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UnknownNCT01908374

Bioavailability of EPA and DHA From Two Dietary Supplements

A Randomized, Controlled, Crossover Study to Evaluate the Acute and Subchronic Bioavailability of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) From Two Dietary Supplements in Men and Women With Mildly Elevated Triglycerides

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Arctic Nutrition AS · Industry
Sex
All
Age
18 Years – 59 Years
Healthy volunteers
Accepted

Summary

The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.

Detailed description

The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDHA-rich fish oil versus Phospholipid-rich fish oilThis randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.

Timeline

Start date
2013-07-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2013-07-25
Last updated
2013-07-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01908374. Inclusion in this directory is not an endorsement.