Bioavailability of EPA + DHA in a SMEDS Formulation

Midwest Center for Metabolic and Cardiovascular Research

Status

Completed

Conditions

Bioavailability

Treatments

Other: Lovaza (active comparator; already FDA approved)

Dietary Supplement: EPA + DHA in SMEDS Formulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03443076

MB-1705

Details and patient eligibility

About

This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body mass index 18.50-29.99 kg/m2
Good health on basis of medical history and routine laboratory tests
Score of at least 7 on vein access scale
Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
Willing to abstain from alcohol for 24 h prior to clinic admission
No plans to change smoking habits or other nicotine use
Willing to undergo 13 venipunctures during each treatment period

Exclusion criteria

Screening lab test of clinical significance
Positive urine drug screen
Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
Uncontrolled hypertension
Recent history or presence of cancer
Difficulty swallowing capsules
Recent blood donation or blood loss
Recent consumption of high-dose fish oil or fish
Recent use of any prescribed medication or over-the-counter medicinal products, including herbal or dietary supplements (except daily omega-3 fatty acid-free vitamin and/or mineral supplement or occasional use of acetaminophen or non-steroidal anti-inflammatory drugs)
Signs or symptoms of active infection or has recently taken antibiotics
Recent history or strong potential for drug or alcohol abuse
Pregnant, planning to be pregnant during the study, lactating or of childbearing potential and unwilling to commit to use of a medically approved form of contraception throughout the study (note: hormonal contraceptive use is not allowed)