Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation

This is an interventional treatment trial for Dyslipidemia focused on measuring fatty acid Read More

Inclusion Criteria:

The inclusion and exclusion criteria for both studies A and B are identical.

• Postmenopausal women (menopause defined by complete natural cessation of menses for >12 months or a bilateral oophorectomy).
• Age >50 to < 85 years
• BMI >20 to <35 kg/m2
• LDL-cholesterol >100 mg/dL
• CRP <10 ug/dL
• Normal fasting plasma glucose levels (<120 mg/dL)
• Not taking medication known to affect lipid metabolism:

HMG-CoA reductase inhibitors (statins)

• Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
• Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
• Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
• Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
• Probucol
• Anticoagulants (Coumadin, Heparin, Plavix, etc)
• Hormone therapy medications containing estrogen
• Acetylsalicylic acid containing medications, aspirin
• Diphenylhydantoin
• Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) for at least 3 months prior to participation in the study
• Anabolic steroids

• Hydrocortisone

  • Normal kidney function as assessed by serum creatinine and blood urea nitrogen
  • Normal liver function as assessed by serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase and alkaline phosphatase
  • Normal thyroid function as assessed by serum TSH
  • Normal gastrointestinal function
  • Normotensive on or off medication
  • Non-smoker for at least 2 years
  • Alcohol intake < 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study.
  • Consistent physical activity
  • Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.

Exclusion criteria:

• Men
• Women who have had a double mastectomy
• Age < 50 and > 85 years
• BMI < 20 and > 35 kg/m2
• LDL-cholesterol <100 mg/dL
• CRP > 10 ug/dL
• Abnormal fasting plasma glucose levels >120 mg/dL

• Use of medications known to affect lipid metabolism:

  • HMG-CoA reductase inhibitors (statins)
  • Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
  • Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
  • Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
  • Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
  • Anticoagulants (Coumadin, Heparin, Plavix, etc)
  • Hormone therapy medications containing estrogen
  • Probucol
  • Acetylsalicylic acid containing medications, aspirin
  • Diphenylhydantoin
  • Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) in the last 3 months prior to participation in the study
  • Anabolic steroids and hydrocortisone
• Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests.
• Hypothyroidism or hyperthyroidism, as defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
• Gastrointestinal disease
• Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
• Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
• Anemia, as defined by screening haemoglobin <11.7g/dL.
• Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of SGPT or SGOT greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal.
• Type I and II diabetes
• Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
• Smoking or use of nicotine-containing products within the past 2 years
• Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
• Unwillingness to maintain body weight during participation in the study
• Unwillingness to adhere to diet and study protocol
• Weight gain or loss of more than 15 lb within 6 months prior to enrollment
• Vegetarians and those with food allergies or aversions
• Non-English speaking subjects
• No Social Security number
• Women who have a history of difficulty with blood draws
• Blood donation within the past 8 weeks