A Program to Provide Oils for
Clinical Research
(The Omega-3 Oils and Related Reference
Materials (O3O) Program)
What is the O3O Program?
Available Omega-3 Oils
Related Reference Materials
Cost of Oils
Who Qualifies
Contact for the O3O Program
Participating Omega-3 Oil
Manufacturers
Omega-3 Oils (O3O) Program
Advisory Board
The Omega-3 Research Institute, Inc. (O3RI) assists clinical researchers in obtaining clinical-grade omega-3 oils (O3O)and related reference materials (placebos) for clinical nutritional research projects. The O3O Program is a modified version of the previous, highly successful Biomedical Test Materials (BTM) Program of the National Marine Fisheries Service’s Charleston Laboratory and the National Institutes of Health (NIH). The O3O Program draws on the advice of many of the same leaders and experts in the field of omega-3 research who advised the BTM Program. The O3O Program serves as an intermediary between industry and the researcher applying for the needed material. The applicants are provided with advice on their proposed clinical protocols by reviewers recruited from among the members of the Program Advisory Board and other experts. The O3O Program provides independent quality control of oils provided by the manufacturer.
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Products of Pronova Biocare, S/A
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EPAX 2050 TG is a triglyceridic oil containing about 20% EPA and 50% DHA
(EPA:DHA ratio is approximately 1.0:2.5) in 1000 mg.soft-gel capsules -
EPAX 5500 TG is a triglyceridic oil containing about 33% EPA and 22% DHA
(EPA:DHA ratio is approximately 1.5:1.0) in 1000 mg.soft-gel capsules -
EPAX 4510 TG is a triglyceridic oil containing about 45% EPA and 10% DHA
(EPA:DHA ratio is approximately 4.5:1.0) in 1000 mg.soft-gel capsules
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Products of MARTEK Biosciences Corporation
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DHA and DHA ethyl ester (<95% purity). It is available in 500 mg.soft-gel capsule.)
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DHASCO is a triglyceridic DHA-rich algal oil that contains about 50% DHA. It is free of other omega-3s or omega-6s and is available in 500 mg. soft-gel capsule.)
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ARASCO is a triglyceridic AA-rich algal oil that contains about 50% AA. It is free of other omega-6s and omega-3s and is available in 500 mg. soft-gel capsule.)
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Product of Laxdale, Ltd.
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High-purity EPA ethyl ester (~95.0% purity). It is available in 500 mg. soft-gel capsules.
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Product of BASF Health and Nutrition
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OmegaVitTM EPA is microencapsulated menhaden oil. The powder/oil contains about 18% EPA and 12% DHA in triglyceridic form (EPA:DHA ratio is approximately 1.5:1.0). Exact composition could vary seasonally.
Other oils including natural flaxseed oil will become available in the near future. Oils are appropriately stabilized with antioxidants. Each user will be provided with manufacturer’s specifications and independent analytical test results performed by an expert, independent laboratory.
Related Reference Materials (for use as placebos):
· Olive oil in bulk and in softgel capsules (1000 mg/capsule).
The olive oil is stabilized with antioxidants. The antioxidant level of the reference oils can be adjusted to the antioxidant level of the omega-3 oil used in the research. The smell, look and feel of the placebo oil could also be matched to the omega-3 oil provided.
While in some cases the oils will be provided free of charge, in other cases they will be supplied at a discounted price determined by the nature of the oil, the quantity of oil required per month and the size and length of the planned study/trial. Costs of services provided by the O3O Program include, but are not limited to: review of the research protocol, encapsulation, analytical characterization of the oil, shipping and administrative costs. Total yearly costs will be communicated to applicant researchers to allow timely inclusion of these cost item into their research budget.
In order to qualify, potential users will have to submit a Letter of Intent and a study protocol for confidential scientific evaluation (review). Upon the applicant’s proof of Institutional Review Board approval of the protocol, the approval of the Investigational New Drug Application by the United States Food and Drug Administration, the provision of an institutional statement assuming all liabilities for the conduct of the planned clinical study/trial, and proof of funding for the proposed project, O3RI will ship the approved materials to the user.
For details on the application process, interested parties should contact Robert Katz, Ph.D., O3O Program Director, at the Omega-3 Research Institute, Inc., 3 Bethesda Metro Center, Suite 700, Bethesda, Maryland 20814 by completing the attached Letter of Intent and "Submitting" it electronically.
!! To express interest please provide us with your E-mail address !!
Participating Omega-3 Oil Manufacturers
BASF Health and Nutrition, A/S.
Laxdale, Ltd.
Martek Biosciences Corporation
Monsanto Corporation
Pronova Biocare, A/S.
Omega-3 Oils (O3O) Program Advisory Board
Robert G. Ackman, Ph.D.,
Patricia A. Fair, Ph.D.,
Norman Salem, Jr., Ph.D.,
Artemis P. Simopoulos, M.D.,
Herbert Woolf, Ph.D.