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CompletedNCT02865044Updated Aug 12, 2016

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

An interventional study of Wax Ester Marine Oil and Ethyl Ester Marine Oil in Healthy, sponsored by Calanus. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-12.

Sponsored by Calanus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

Read the detailed description

A randomized, controlled two-period crossover study included one screening/baseline visit (visit 1, day -7) with four test visits during Period I (visits 2, 3, 4, and 5; days 0, 1, 2, and 3) and four tests visits during Period II (visits 6, 7, 8, and 9; days 14, 15, 16, and 17) with at least a 7-d washout between test periods. Eighteen healthy adults with fasting TAG concentrations \<200 mg/dL were randomly assigned to one of two treatment sequences: receive 8 capsules containing Calanus oil® (Calanus AS, Tromso, Norway) supplying a total of 4 g of oil providing 260 mg EPA and 156 mg/day DHA primarily as wax esters, followed by 1 capsule supplying 1 g of oil providing 465 mg EPA and 375 mg DHA as ethyl esters (Lovaza®, GlaxoSmithKline, Research Triangle Park, NC); or, to receive Lovaza followed by Calanus Oil. Product was dispensed in-clinic with an standardized EPA- and DHA- free breakfast meal (t=0). Blood samples were obtained in-clinic at t= -30 min, and 1, 2, 4, 6, 8, 10 and 12 h timepoints. Subjects were provided a standardized EPA- and DHA-free meal at t=4 h and t=8. Subject were dismissed from the clinic after t-12 h blood draw and returned the morning of days 1, 2 and 3 (days 15, 16 and 17) for a 24 h, 48 h and 72 h fasting blood draw.

02

Conditions studied

  • Healthy

Keywords

  • Fatty Acids
  • Fish Oil
  • Marine Copepod
  • Fatty Acid Absorption
03

In context

Lead sponsor

This is the only study on the registry with Calanus as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female, 18-59 years of age, inclusive.
  2. BMI of ≥18.50 and ≤29.99 kg/m2 at visit 1 (day -7).
  3. Fasting TG \<200 mg/dL at visit 1 (day -7).
  4. Score of 7 to 10 on the Vein Access Scale at visit 1 (day -7).
  5. 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.
  6. 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.
  7. Willing to limit alcohol consumption to no more than 1 drink/d following visit 1 (day -7) and throughout the study.
  8. Non-smoker with no plans to change smoking habits during the study period.
  9. Willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
  10. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. History of difficulty swallowing tablets/capsules that could have affected ability to consume the study products.
  5. Extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Investigator.
  6. 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.
  7. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
  8. Weight loss or gain >4.5 kg in the 3 months prior to visit 1 (day -7).
  9. 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).
  10. 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).
  11. Known allergy or sensitivity to omega-3 fatty acids, fish, other seafood, or any ingredient in the study product or study meals.
  12. 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).
  13. 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.
  14. Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).
  15. 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).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Wax Ester Marine Oil

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

    Other: Wax Ester Marine Oil

  • Other
    Ethyl Ester Marine Oil

    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

  • OtherWax Ester Marine Oil

    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

  • OtherEthyl Ester Marine Oil

    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

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

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

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

  2. iAUCs for plasma EPA+DHA

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

  3. The iAUCs for plasma EPA and DHA alone

    Time frame: (iAUC-0.5-24 h, iAUC-0.5-48 h, iAUC-0.5-72 h).

07

Study locations

1 site
  • Biofortis Clinical Research
    Addison, Illinois 60101, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02865044
Lead sponsor
Calanus
Collaborators
Biofortis Clinical Research, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2016
Start date
Mar 2015
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Aug 12, 2016

Study contacts

Chad Cook, PhD
study director · Biofortis Clinical Research, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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