Clinical Trials

Inclusion Criteria:

• Age > 21 to < 65 years 
• Able to give informed consent
• Unwilling to use or intolerant of at-least one statin medication

Exclusion Criteria

• Unable to speak/read in English 
• Unable or unwilling to temporarily hold all statin/lipid lowering therapies including supplements throughout the study period
• Has diabetes or severe obesity (body mass index, BMI, > 35 kg/m2)
• Pregnant or planning to be pregnant during the study period
• Any food allergies/intolerances, or food restrictions due to medical, religious or philosophical reason - including Kosher, vegan, vegetarian, high protein, low-carbohydrate, low-phosphorus, etc. other than attempting to follow an eating plan as generally advocated by the American Heart Association (low sodium, low cholesterol, reduced fat, etc.)
• Baseline fasting LDL-C is < 100 mg/dL or > 190 mg/dL
• Evidence of tissue cholesterol deposition 
• Baseline fasting TG is > 400 mg/dL or baseline fasting blood glucose is > 126 mg/dL
• Consumption of more than 2 alcoholic drink/day or history of alcoholism or drug dependence
• Smokes
• History of non-skin cancer
• History of melanoma
• History of rheumatoid arthritis or other chronic rheumatologic condition
• History of advanced cardiovascular disease
  • Moderate or greater valvular disease
  • History congestive heart failure
  • Known coronary artery disease
  • History dysrhythmias requiring medical or surgical intervention
• Known chronic liver or renal disease, diabetes, inflammatory bowel disease, celiac disease, uncontrolled thyroid disease, hormonal supplementation(other than thyroid), pancreatitis, gallbladder or biliary disease, neurological/psychological disease, and gastrointestinal disorders that could interfere with fat absorption
• Uncontrolled hypertension having systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg