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

Lipid Metabolism Disorders Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases

• NCT number: NCT02270164
• Study type: Interventional
• Source: University of Mississippi Medical Center
• Status: Withdrawn
• Phase: N/A
• Start date: October 2014
• Completion date: February 2016