HealthyNCT02865044
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women
A study testing Wax Ester Marine Oil and Ethyl Ester Marine Oil in people with Healthy, run by Calanus at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wax Ester Marine Oil and Ethyl Ester Marine Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Controlled, Crossover Study to Evaluate the Acute Bioavailability of Eicosapentaenoic Acid andDocosahexaenoic Acid From a DietarySupplement in Healthy Men and Women: A 72-Hour Study With Controlled Feeding
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.
- Conditions
- Healthy
- Being tested
- Wax Ester Marine Oil, Ethyl Ester Marine Oil
- Keywords
- Fatty Acids, Fish Oil, Marine Copepod, Fatty Acid Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wax Ester Marine OilOther
Also called Calanus Oil, marine copepod Calanus finmarchicus
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.
Ethyl Ester Marine OilOther
Also called Lovaza
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Ethyl Ester Marine Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the curve (iAUC) for plasma EPA+DHA
Measured: 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
Measured: pre-product consumption (t = -0.5 h) to 72 h
iAUCs for plasma EPA+DHA
Measured: 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
Measured: (iAUC-0.5-24 h, iAUC-0.5-48 h, iAUC-0.5-72 h).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calanus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Chad Cook, PhD, Study director, Biofortis Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865044
- Sponsor's protocol ID
- BIO 1505
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Crossover Study to Evaluate the Acute Bioavailability of Eicosapentaenoic Acid andDocosahexaenoic Acid From a DietarySupplement in Healthy Men and Women: A 72-Hour Study With Controlled Feeding
- ClinicalTrials.gov ID
- NCT02865044
- Acronym / sponsor ID
- BIO 1505
- Conditions
- Healthy
- Keywords
- Fatty Acids, Fish Oil, Marine Copepod, Fatty Acid Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CalanusIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wax Ester Marine Oil | Active comparator | Other: Wax Ester Marine OilActive: Wax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules) |
| Ethyl Ester Marine Oil | Other | Other: Ethyl Ester Marine OilControl: Ethyl ester (EE) marine oil (Lovaza OM3 EE; 1 g providing 465 mg EPA and 375 mg DHA; 1 capsule) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wax Ester Marine OilAlso: Calanus Oil, marine copepod Calanus finmarchicusWax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules) consumed once, in clinic, at t=0. | Other | Wax Ester Marine Oil |
| Ethyl Ester Marine OilAlso: LovazaEthyl 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 | Other | Ethyl Ester Marine Oil |
Primary outcome
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)
3 secondary outcomes
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
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Cook, PhD study director
Biofortis Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wax Ester Marine Oil and Ethyl Ester Marine Oil in people with Healthy, run by Calanus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.