Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women

NCT02865044 | Completed

• 1 other identifier: BIO 1505
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate and compare the acute bioavailability of EPA and DHA in wax ester form provided as a dietary supplement compared to a well-studied and defined ethyl ester formulation in generally healthy men and women.

Conditions

Healthy

Keywords

Fatty Acids; Fish Oil; Marine Copepod; Fatty Acid Absorption

Outcome Measures

Primary Outcomes (1)

• Incremental area under the curve (iAUC) for plasma EPA+DHA

  pre-product consumption (t = -0.5 h) to 72 h (iAUC-0.5-72h)

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax) and time to Cmax (Tmax) for EPA, DHA, and EPA+DHA

  pre-product consumption (t = -0.5 h) to 72 h

• iAUCs for plasma EPA+DHA

  pre-product consumption (t = -0.5 h) to 24 h (iAUC-0.5-24 h), and to 48 h (iAUC-0.5-48 h)

• The iAUCs for plasma EPA and DHA alone

  (iAUC-0.5-24 h, iAUC-0.5-48 h, iAUC-0.5-72 h).

Study Arms (2)

Wax Ester Marine Oil

ACTIVE COMPARATOR

Active: Wax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules)

Other: Wax Ester Marine Oil

Ethyl Ester Marine Oil

OTHER

Control: Ethyl ester (EE) marine oil (Lovaza OM3 EE; 1 g providing 465 mg EPA and 375 mg DHA; 1 capsule)

Other: Ethyl Ester Marine Oil

Interventions

Wax Ester Marine Oil OTHER

Wax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules) consumed once, in clinic, at t=0.

Also known as: Calanus Oil, marine copepod Calanus finmarchicus

Wax Ester Marine Oil

Ethyl Ester Marine Oil OTHER

Ethyl ester (EE) marine oil (Lovaza OM3 EE; 1 g providing 465 mg EPA and 375 mg DHA; 1 capsule), consumed once, in clinic, at t=0

Also known as: Lovaza

Ethyl Ester Marine Oil

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18-59 years of age, inclusive.
• BMI of ≥18.50 and ≤29.99 kg/m2 at visit 1 (day -7).
• Fasting TG \<200 mg/dL at visit 1 (day -7).
• Score of 7 to 10 on the Vein Access Scale at visit 1 (day -7).
• No health conditions that would prevent the subject from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
• Willing to refrain from consumption of all fish/seafood (including shellfish), and/or EPA- or DHA-containing foods and supplements 14 d prior to visit 2 (day 0) and throughout the study.
• Willing to limit alcohol consumption to no more than 1 drink/d following visit 1 (day -7) and throughout the study.
• Non-smoker with no plans to change smoking habits during the study period.
• Willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
• Understood the study procedures and signed forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the study Investigator.

You may not qualify if:

• Abnormal laboratory test results of clinical significance at visit 1 (day -7), at the discretion of the Investigator. One re-test was allowed on a separate day prior to visit 2 (day 0) for subjects with abnormal laboratory test results.
• History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders.
• History or presence of a GI disorder that, in the judgment of the Investigator, may have disrupted normal digestion and absorption of the study products.
• History of difficulty swallowing tablets/capsules that could have affected ability to consume the study products.
• Extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1 (day -7). One re-test was allowed on a separate day prior to visit 2 (day 0), for subjects whose blood pressure exceeded either of these cut points, in the judgment of the Investigator.
• History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Weight loss or gain \>4.5 kg in the 3 months prior to visit 1 (day -7).
• Use of medications or dietary supplements known to alter lipid concentrations within 4 weeks of visit 1 (day -7). Dietary supplements included, but were not limited to, the following: sterol/stanol products; dietary fiber supplements (including \>1 teaspoon Metamucil® or viscous fiber-containing supplement per day); red rice yeast supplements; garlic supplements; soy isoflavone supplements; or niacin or its analogues at dosages \>50 mg/day (or others at the discretion of the Investigator).
• Use of non-study related omega-3-acid ethyl ester drug(s) or dietary supplement(s) with ≥1.0 g/d of EPA, DHA, or a combination of EPA and DHA within 4 months of visit 1 (day -7).
• Known allergy or sensitivity to omega-3 fatty acids, fish, other seafood, or any ingredient in the study product or study meals.
• Active infection or use of antibiotics within 5 d of visits 2 and 6 (days 0 and 14). Subjects that had an active infection and/or were using antibiotics were required to wait at least 5 d after the infection resolved or antibiotic use was complete prior to the first day of each test period (visits 2 and 6, days 0 and 14).
• Female who was pregnant, planning to be pregnant during the study period, lactating, or was of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception was recorded in the source documentation.
• Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
• Recent history of (within 12 months of screening; visit 1, day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).

Sponsors & Collaborators

• Calanus: lead
• Biofortis Clinical Research, Inc.: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

MeSH Terms

Interventions

Omacor

Study Officials

• Chad Cook, PhD

  Biofortis Clinical Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

US (1)