- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865044
Study to Evaluate the Acute Bioavailability of EPA and DHA From a DietarySupplement in Healthy Men and Women
August 11, 2016 updated by: Calanus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
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.
Other Names:
|
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)
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
pre-product consumption (t = -0.5 h) to 72 h (iAUC-0.5-72h)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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)
|
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).
|
(iAUC-0.5-24 h, iAUC-0.5-48 h, iAUC-0.5-72 h).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Chad Cook, PhD, Biofortis Clinical Research, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
August 9, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimate)
August 12, 2016
Study Record Updates
Last Update Posted (Estimate)
August 12, 2016
Last Update Submitted That Met QC Criteria
August 11, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- BIO 1505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Wax Ester Marine Oil
-
Orion Corporation, Orion PharmaCompleted
-
Hospital Authority, Hong KongUnknownCerumen Impaction of Both EarsHong Kong
-
DSM Nutritional Products, Inc.Completed
-
Supplement Formulators, Inc.CompletedInflammationUnited States
-
Supplement Formulators, Inc.TerminatedInflammation | Inflammatory ResponseUnited States
-
Brigham and Women's HospitalUnknownPatients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled | Persistent Post Surgical Pain
-
KU LeuvenRecruitingExercise | Healthy Male/Female SubjectsBelgium
-
Aalborg University HospitalCompletedPostmenopause | PremenopauseDenmark
-
University of CopenhagenDanish Research Agency; Technical University of Denmark; HjerteforeningenUnknownMetabolic Syndrome | Cardiovascular Heart DiseaseDenmark
-
NORCE Norwegian Research Centre ASUniversity of Bergen; The Research Council of Norway; Haukeland University HospitalCompletedChronic Low Back PainNorway