Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | DHA-rich fish oil versus Phospholipid-rich fish oil | This 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.