The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study

Subjects will be divided into one of two groups: (1) Pycrinil®/flaxseed oil or (2)
Placebo/flaxseed oil twice daily with food. The two formulations will be identical in
appearance and standardized by Indena, S.p.A. Patients will be enrolled for a total of 3
months (± 1 week to allow for scheduling flexibility) with a 1 month (± 1 week to allow for
scheduling flexibility) first follow-up visit in between enrollment and final visits. At all
visits, patients will be asked to monitor for any symptomatic ADE. The first follow-up visit
will focus on medication compliance (via pill count) and safety assessment (including
laboratories). The final study visit will consist of brief clinical assessment (including
anthropometrics), completed lifestyle and physical activity assessments, subjective ADE
reporting, and donated blood and urine for clinical laboratory tests. Medication changes are
not prohibited during the study period, but must be recorded. Medication bottles will be
collected at the first follow-up and final visits; pill counts will be performed to assess
compliance.

Inclusion Criteria:

- ≥18 years of age

- HDL cholesterol <40 mg/dL in men or <50 mg/dL in women

- BMI ≥25 kg/m2.

Exclusion Criteria:

- Patient on statins

- Triglycerides >400 mg/dL

- Low density lipoprotein (LDL) >190 mg/dL

- Significant hepatic disease (i.e., documented diagnosis of hepatic cancer, hepatitis,
or cirrhosis)

- Significant renal disease (i.e., most recent glomerular filtration rate <30
mL/min/1.73 m2)

- Significant gastrointestinal tract disease (documented diagnosis of malabsorption
disorder, GI cancer, or uncontrolled inflammatory bowel disease)

- History of transplant

- Women of reproductive potential not receiving birth control

- Pregnant/nursing women