Diet-induced Elevations in LDL-C and Progression of Atherosclerosis

Prior treatment

• Use of medications that elevated LDL-C (anabolic steroids, isotretinoin, immunosuppressants, amiodarone, thiazide diuretics, glucocorticoids, or thiazolidinediones)
• Use of Lipid lowering medication (Statins, etc) at the time of most recent labs taken before starting Ketogenic diet.

Other illness

• An ongoing inflammatory disorder (e.g. psoriatic arthritis)
• History of atherosclerotic heart disease
• Known history of molecularly defined Familial Hypercholesterolemia
• Subjects with known allergy to iodinated contrast material

Lab values

• Renal insufficiency (calculated creatinine clearance of \<50 ml per minute, MDRD (modification of Diet in Renal Disease) equation).
• AST (Aspartate aminotransferase) or ALT (Alanine Transaminase) \>2 times the upper limit of normal (ULN) at the Screening visit (V1), or a total bilirubin \>1.5 times the ULN unless the subject has a history of Gilbert's.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality at the Screening visit (V1) that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Age

• Subject has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• Note (1) A subject with a history of malignancy \>5 years prior to signing informed consent should have no evidence of residual or recurrent disease.

Other

• Untreated hypothyroidism (TSH \> 10)
• Pregnancy
• Has smoked more than 100 cigarettes in lifetime
• BMI = or \> 30 kg/m\^2 (or waist circumference \> 88 cm or \> 102 cm for women and men respectively if BMI between 25-30 kg/m\^2)
• Subject unable to provide medical records indicating lab results before starting a keto- diet.
• Subject is pregnant or breast-feeding, or is expecting to conceive during the study period.

• Age ≥ 18 years old
• Had an LDL cholesterol of 160 mg/dL or below from most recent labs taken before adopting a low carb diet (requires documentary evidence)
• Has seen an increase of LDL cholesterol to 190 mg/dL or above from most recent labs on current diet \*\*
• Has LDL cholesterol levels at least 50% or greater compared to most recent documented value prior to starting the diet.
• On low carb, ketogenic diet for the last 24 months or more.
• HDL-C ≥ 60 mg/dL and triglyceride level ≤ 80 mg/dL \*\*
• Willingness to participate in the study and ability to sign informed consent
• In the investigator's opinion subjects are willing and likely able to comply with scheduled visits, laboratory tests, and other study procedures.
• Normal to low BP (systolic ≤ 130 mm Hg or diastolic ≤ 80 mm Hg) at screening/baseline (visit 1).
• Fasting glucose \< 110 mg/dL and HbA1c \< 6.0%) \*\*
• hsCRP \< 2 mg/L \*\*
• No prior diagnosis of Type 2 Diabetes
• No prior use of anti-diabetic medication
• Not currently taking lipid lowering supplements or medications including statins, red yeast rice, garlic, ezetimibe, berberine
  • Requires documentary evidence