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

Not Applicable

Withdrawn

• Conditions: Lipid Metabolism Disorders
• Interventions: Dietary Supplement: Artichoke Leaf Extract; Other: Placebo

• Registration Number: NCT02270164
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artichoke Leaf Extract	Artichoke Leaf Extract	Pycrinil® 100 mg/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food
Placebo	Placebo	Placebo/flaxseed oil 380 mg liquid filled hard plant based capsules (Licaps®) twice daily with food

Primary Outcome Measures

Name	Time	Method
Change in Concentrations of High Density Lipoprotein Cholesterol	3 months

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States