Study of the Safety and Efficacy of Dietary Buglossoides Oil

You may not qualify if:

• Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. Method of contraception must be recorded in the case report file.
• Individual has a condition the study physician believes would interfere with the participant's ability to provide informed consent, comply with his responsibilities during the study, which might confound the interpretation of the study results or put the person at undue risk.
• Medical conditions including an active peptic ulcer, inflammatory bowel disease, or gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery that could influence absorption, metabolism or excretion of the study supplement.
• History or presence of significant, renal, hepatic, gastrointestinal, pulmonary, biliary, neurological or endocrine disorders.
• History or presence of cancer in the past 2 yrs, except for non-melanoma skin cancers (e.g. basal or squamous cell carcinoma of the skin).
• Clinically significant abnormal laboratory test results including but not limited to LDL-cholesterol ≥ 4.1mM, triglyceride levels ≥3.95mM, fasting creatinine ≥ 1.5 mg/dL, alkaline phosphatase or aspartate aminotransferase ≥ 1.5 times the upper limit of normal.
• Currently being treated for angina, arrhythmia and/or congestive heart failure. History of myocardial infarction or stroke.
• Presence of coronary heart disease or presence of multiple risk factors that result in a greater than 20% chance for developing coronary artery disease within 10 years using the Framingham risk index.
• Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.
• If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.
• History (within 12 months) or current alcohol or substance abuse (no more than 14 consumptions per week; 1 consumption= 12 oz beer, 5 oz wine, 1.5 oz distilled spirits).
• Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription formulations of niacin).
• Use of any weight loss or lipid metabolism medication/supplement/program (including lipase inhibitors) within 1 month of study period OR weight gain or loss \> 2 kg in the past 3 months.
• Currently taking fish oil or any other omega-3 or omega-6 polyunsaturated fatty acid supplement/drug within three months of Visit 1 and throughout the study. Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than twice a month within three months of visit 1 and throughout the study period. Consumption (more than twice a month) of any EPA/DHA enriched foods (e.g. DHA-enriched eggs) within three months of Visit 1. Unwillingness to avoid all fish including shellfish and crustaceans throughout the study period.
• +3 more criteria