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

Study Overview
=================
Brief Summary
-----------------
Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some clinical trial data suggesting benefit in the treatment of cholesterol disorders in several countries, but this effect has not been studied in a U.S. population. The investigators will give ALE or a placebo to overweight men and women with low good cholesterol to see if ALE increases their good cholesterol. The investigators will also make sure that ALE is safe.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Lipid Metabolism Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: Artichoke Leaf Extract
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artichoke Leaf Extract<br>Pycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food | Dietary Supplement: Artichoke Leaf Extract<br>* Capsule<br>* Other names: Pycrinil;|
| Placebo Comparator: Placebo<br>Placebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food | Other: Placebo<br>* Capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Concentrations of High Density Lipoprotein Cholesterol |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipids, Cholesterol, Dietary Supplements, Cynara scolymus, Safety